{"product_id":"onctose-hydrocortisone-anti-itch-cream-30-g","title":"Onctose Hydrocortisone – Anti-Itch Cream (30 g)","description":"\u003ch2 data-start=\"138\" data-end=\"157\"\u003eProduct overview\u003c\/h2\u003e\n\u003cp data-start=\"158\" data-end=\"217\"\u003e\u003cstrong data-start=\"158\" data-end=\"184\"\u003eOnctose Hydrocortisone\u003c\/strong\u003e is an anti-itch cream combining:\u003c\/p\u003e\n\u003cul data-start=\"218\" data-end=\"382\"\u003e\n\u003cli data-start=\"218\" data-end=\"279\"\u003e\n\u003cp data-start=\"220\" data-end=\"279\"\u003ea \u003cstrong data-start=\"222\" data-end=\"253\"\u003emild topical corticosteroid\u003c\/strong\u003e (hydrocortisone acetate),\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"280\" data-end=\"341\"\u003e\n\u003cp data-start=\"282\" data-end=\"341\"\u003ean \u003cstrong data-start=\"285\" data-end=\"302\"\u003eantihistamine\u003c\/strong\u003e (mepyramine\/mefenidramium derivative),\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"342\" data-end=\"382\"\u003e\n\u003cp data-start=\"344\" data-end=\"382\"\u003eand a \u003cstrong data-start=\"350\" data-end=\"370\"\u003elocal anesthetic\u003c\/strong\u003e (lidocaine)\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-start=\"384\" data-end=\"465\"\u003eIt’s mainly used to \u003cstrong data-start=\"404\" data-end=\"423\"\u003erelieve itching\u003c\/strong\u003e, especially from \u003cstrong data-start=\"441\" data-end=\"464\"\u003einsect bites\/stings\u003c\/strong\u003e.\u003c\/p\u003e\n\u003ch2 data-start=\"467\" data-end=\"482\"\u003eWho it’s for\u003c\/h2\u003e\n\u003cul data-start=\"483\" data-end=\"656\"\u003e\n\u003cli data-start=\"483\" data-end=\"530\"\u003e\n\u003cp data-start=\"485\" data-end=\"530\"\u003e\u003cstrong data-start=\"485\" data-end=\"530\"\u003eAdults, adolescents, children ≥ 30 months\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"531\" data-end=\"576\"\u003e\n\u003cp data-start=\"533\" data-end=\"576\"\u003e\u003cstrong data-start=\"533\" data-end=\"547\"\u003ePregnancy:\u003c\/strong\u003e only \u003cstrong data-start=\"553\" data-end=\"576\"\u003ewith medical advice\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"577\" data-end=\"656\"\u003e\n\u003cp data-start=\"579\" data-end=\"656\"\u003e\u003cstrong data-start=\"579\" data-end=\"597\"\u003eBreastfeeding:\u003c\/strong\u003e only \u003cstrong data-start=\"603\" data-end=\"626\"\u003ewith medical advice\u003c\/strong\u003e (do \u003cstrong data-start=\"631\" data-end=\"638\"\u003enot\u003c\/strong\u003e apply on breasts)\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 data-start=\"658\" data-end=\"672\"\u003eIndications\u003c\/h2\u003e\n\u003cul data-start=\"673\" data-end=\"727\"\u003e\n\u003cli data-start=\"673\" data-end=\"727\"\u003e\n\u003cp data-start=\"675\" data-end=\"727\"\u003eItching \/ pruritus, especially from \u003cstrong data-start=\"711\" data-end=\"727\"\u003einsect bites\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 data-start=\"729\" data-end=\"755\"\u003eDirections (how to use)\u003c\/h2\u003e\n\u003cul data-start=\"756\" data-end=\"933\"\u003e\n\u003cli data-start=\"756\" data-end=\"775\"\u003e\n\u003cp data-start=\"758\" data-end=\"775\"\u003e\u003cstrong data-start=\"758\" data-end=\"775\"\u003eSkin use only\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"776\" data-end=\"820\"\u003e\n\u003cp data-start=\"778\" data-end=\"820\"\u003eApply \u003cstrong data-start=\"784\" data-end=\"820\"\u003e1 application, 2–3 times per day\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"821\" data-end=\"847\"\u003e\n\u003cp data-start=\"823\" data-end=\"847\"\u003e\u003cstrong data-start=\"823\" data-end=\"847\"\u003eWash hands after use\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"848\" data-end=\"874\"\u003e\n\u003cp data-start=\"850\" data-end=\"874\"\u003e\u003cstrong data-start=\"850\" data-end=\"874\"\u003eMax duration: 3 days\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"875\" data-end=\"933\"\u003e\n\u003cp data-start=\"877\" data-end=\"933\"\u003eIf itching persists \u003cstrong data-start=\"897\" data-end=\"914\"\u003ebeyond 3 days\u003c\/strong\u003e, consult a doctor.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 data-start=\"935\" data-end=\"956\"\u003eDo NOT use \/ Avoid\u003c\/h2\u003e\n\u003cp data-start=\"957\" data-end=\"970\"\u003eDo not apply:\u003c\/p\u003e\n\u003cul data-start=\"971\" data-end=\"1161\"\u003e\n\u003cli data-start=\"971\" data-end=\"991\"\u003e\n\u003cp data-start=\"973\" data-end=\"991\"\u003eon \u003cstrong data-start=\"976\" data-end=\"991\"\u003elarge areas\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"992\" data-end=\"1088\"\u003e\n\u003cp data-start=\"994\" data-end=\"1088\"\u003eunder \u003cstrong data-start=\"1000\" data-end=\"1022\"\u003eocclusive dressing\u003c\/strong\u003e (including \u003cstrong data-start=\"1034\" data-end=\"1049\"\u003ediaper area\u003c\/strong\u003e \/ under a layer that “seals” the skin)\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"1089\" data-end=\"1108\"\u003e\n\u003cp data-start=\"1091\" data-end=\"1108\"\u003e\u003cstrong data-start=\"1091\" data-end=\"1108\"\u003enear the eyes\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"1109\" data-end=\"1161\"\u003e\n\u003cp data-start=\"1111\" data-end=\"1161\"\u003eon \u003cstrong data-start=\"1114\" data-end=\"1134\"\u003emucous membranes\u003c\/strong\u003e (including intimate areas)\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-start=\"1163\" data-end=\"1177\"\u003eDo not use if:\u003c\/p\u003e\n\u003cul data-start=\"1178\" data-end=\"1394\"\u003e\n\u003cli data-start=\"1178\" data-end=\"1255\"\u003e\n\u003cp data-start=\"1180\" data-end=\"1255\"\u003eallergy to \u003cstrong data-start=\"1191\" data-end=\"1212\"\u003elocal anesthetics\u003c\/strong\u003e, \u003cstrong data-start=\"1214\" data-end=\"1232\"\u003eantihistamines\u003c\/strong\u003e, or \u003cstrong data-start=\"1237\" data-end=\"1255\"\u003ehydrocortisone\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"1256\" data-end=\"1348\"\u003e\n\u003cp data-start=\"1258\" data-end=\"1348\"\u003e\u003cstrong data-start=\"1258\" data-end=\"1275\"\u003einfected skin\u003c\/strong\u003e of any kind (viral, bacterial, fungal): \u003cstrong data-start=\"1316\" data-end=\"1342\"\u003eacne, rosacea, mycosis\u003c\/strong\u003e, etc.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"1349\" data-end=\"1394\"\u003e\n\u003cp data-start=\"1351\" data-end=\"1394\"\u003e\u003cstrong data-start=\"1351\" data-end=\"1369\"\u003eweeping\/oozing\u003c\/strong\u003e or \u003cstrong data-start=\"1373\" data-end=\"1386\"\u003eulcerated\u003c\/strong\u003e lesions\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3 data-start=\"1396\" data-end=\"1408\"\u003eChildren\u003c\/h3\u003e\n\u003cul data-start=\"1409\" data-end=\"1504\"\u003e\n\u003cli data-start=\"1409\" data-end=\"1446\"\u003e\n\u003cp data-start=\"1411\" data-end=\"1446\"\u003e\u003cstrong data-start=\"1411\" data-end=\"1446\"\u003eContraindicated under 30 months\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"1447\" data-end=\"1504\"\u003e\n\u003cp data-start=\"1449\" data-end=\"1504\"\u003e\u003cstrong data-start=\"1449\" data-end=\"1468\"\u003eOver 30 months:\u003c\/strong\u003e allowed, \u003cstrong data-start=\"1478\" data-end=\"1504\"\u003eexcept not on the face\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 data-start=\"1506\" data-end=\"1541\"\u003ePossible side effects (key ones)\u003c\/h2\u003e\n\u003cul data-start=\"1542\" data-end=\"1784\"\u003e\n\u003cli data-start=\"1542\" data-end=\"1570\"\u003e\n\u003cp data-start=\"1544\" data-end=\"1570\"\u003e\u003cstrong data-start=\"1544\" data-end=\"1570\"\u003eAllergic skin reaction\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"1571\" data-end=\"1731\"\u003e\n\u003cp data-start=\"1573\" data-end=\"1731\"\u003eWith prolonged use: \u003cstrong data-start=\"1593\" data-end=\"1610\"\u003eskin thinning\u003c\/strong\u003e, \u003cstrong data-start=\"1612\" data-end=\"1629\"\u003estretch marks\u003c\/strong\u003e, acne-like eruptions, irritation\/redness, pigment changes, delayed healing, secondary skin infections\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"1732\" data-end=\"1784\"\u003e\n\u003cp data-start=\"1734\" data-end=\"1784\"\u003e\u003cstrong data-start=\"1734\" data-end=\"1753\"\u003eVision problems\u003c\/strong\u003e if applied \u003cstrong data-start=\"1765\" data-end=\"1784\"\u003ein\/near the eye\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 data-start=\"1786\" data-end=\"1811\"\u003eAthletes (doping note)\u003c\/h2\u003e\n\u003cp data-start=\"1812\" data-end=\"1891\"\u003eContains an active ingredient that \u003cstrong data-start=\"1847\" data-end=\"1890\"\u003emay trigger a positive anti-doping test\u003c\/strong\u003e.\u003c\/p\u003e\n\u003ch2 data-start=\"1893\" data-end=\"1927\"\u003eComposition (actives per 100 g)\u003c\/h2\u003e\n\u003cul data-start=\"1928\" data-end=\"2034\"\u003e\n\u003cli data-start=\"1928\" data-end=\"1964\"\u003e\n\u003cp data-start=\"1930\" data-end=\"1964\"\u003eHydrocortisone acetate \u003cstrong data-start=\"1953\" data-end=\"1964\"\u003e0.250 g\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"1965\" data-end=\"1992\"\u003e\n\u003cp data-start=\"1967\" data-end=\"1992\"\u003eLidocaine HCl \u003cstrong data-start=\"1981\" data-end=\"1992\"\u003e1.000 g\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"1993\" data-end=\"2034\"\u003e\n\u003cp data-start=\"1995\" data-end=\"2034\"\u003eMefenidramium methylsulfate \u003cstrong data-start=\"2023\" data-end=\"2034\"\u003e2.000 g\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 data-start=\"2036\" data-end=\"2048\"\u003ePack size\u003c\/h2\u003e\n\u003cul data-start=\"2049\" data-end=\"2064\"\u003e\n\u003cli data-start=\"2049\" data-end=\"2064\"\u003e\n\u003cp data-start=\"2051\" data-end=\"2064\"\u003e\u003cstrong data-start=\"2051\" data-end=\"2064\"\u003eTube 30 g\u003c\/strong\u003e\u003cstrong data-start=\"2051\" data-end=\"2064\"\u003e\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cspan style=\"color: rgb(255, 42, 0);\"\u003e\u003cstrong data-start=\"2051\" data-end=\"2064\"\u003ePlease read the following full disclosure before purchasing or using this product. \u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003ch2 data-start=\"175\" data-end=\"212\"\u003eSUMMARY OF PRODUCT CHARACTERISTICS\u003c\/h2\u003e\n\u003cp data-start=\"214\" data-end=\"249\"\u003e\u003cstrong data-start=\"214\" data-end=\"249\"\u003eANSM – Last updated: 29\/08\/2023\u003c\/strong\u003e\u003c\/p\u003e\n\u003ch3 data-start=\"251\" data-end=\"287\"\u003e1. NAME OF THE MEDICINAL PRODUCT\u003c\/h3\u003e\n\u003cp data-start=\"289\" data-end=\"322\"\u003e\u003cstrong data-start=\"289\" data-end=\"315\"\u003eONCTOSE HYDROCORTISONE\u003c\/strong\u003e, cream\u003c\/p\u003e\n\u003ch3 data-start=\"324\" data-end=\"371\"\u003e2. QUALITATIVE AND QUANTITATIVE COMPOSITION\u003c\/h3\u003e\n\u003cp data-start=\"373\" data-end=\"667\"\u003eHydrocortisone acetate .............................................................. \u003cstrong data-start=\"459\" data-end=\"470\"\u003e0.250 g\u003c\/strong\u003e\u003cbr data-start=\"470\" data-end=\"473\"\u003eLidocaine hydrochloride .............................................................. \u003cstrong data-start=\"560\" data-end=\"571\"\u003e1.000 g\u003c\/strong\u003e\u003cbr data-start=\"571\" data-end=\"574\"\u003eMefenidramium methylsulfate ..................................................... \u003cstrong data-start=\"656\" data-end=\"667\"\u003e2.000 g\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp data-start=\"669\" data-end=\"687\"\u003ePer 100 g of cream\u003c\/p\u003e\n\u003cp data-start=\"689\" data-end=\"739\"\u003eExcipient with known effect: \u003cstrong data-start=\"718\" data-end=\"738\"\u003epropylene glycol\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp data-start=\"741\" data-end=\"790\"\u003eFor the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003ch3 data-start=\"792\" data-end=\"818\"\u003e3. PHARMACEUTICAL FORM\u003c\/h3\u003e\n\u003cp data-start=\"820\" data-end=\"826\"\u003eCream.\u003c\/p\u003e\n\u003ch3 data-start=\"828\" data-end=\"855\"\u003e4. CLINICAL PARTICULARS\u003c\/h3\u003e\n\u003ch4 data-start=\"857\" data-end=\"890\"\u003e4.1. Therapeutic indications\u003c\/h4\u003e\n\u003cp data-start=\"892\" data-end=\"987\"\u003eLocal symptomatic treatment of \u003cstrong data-start=\"923\" data-end=\"945\"\u003epruritus (itching)\u003c\/strong\u003e, particularly following \u003cstrong data-start=\"970\" data-end=\"986\"\u003einsect bites\u003c\/strong\u003e.\u003c\/p\u003e\n\u003ch4 data-start=\"989\" data-end=\"1036\"\u003e4.2. Posology and method of administration\u003c\/h4\u003e\n\u003cp data-start=\"1038\" data-end=\"1048\"\u003e\u003cstrong data-start=\"1038\" data-end=\"1048\"\u003eDosage\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp data-start=\"1050\" data-end=\"1087\"\u003e1 application \u003cstrong data-start=\"1064\" data-end=\"1086\"\u003e2 to 3 times daily\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp data-start=\"1089\" data-end=\"1192\"\u003eIncreasing the number of applications may worsen adverse effects without improving therapeutic benefit.\u003c\/p\u003e\n\u003cp data-start=\"1194\" data-end=\"1238\"\u003eTreatment duration is limited to \u003cstrong data-start=\"1227\" data-end=\"1237\"\u003e3 days\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp data-start=\"1240\" data-end=\"1268\"\u003e\u003cstrong data-start=\"1240\" data-end=\"1268\"\u003eMethod of administration\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp data-start=\"1270\" data-end=\"1289\"\u003eCutaneous use only.\u003c\/p\u003e\n\u003cp data-start=\"1291\" data-end=\"1336\"\u003eWash hands thoroughly after each application.\u003c\/p\u003e\n\u003ch4 data-start=\"1338\" data-end=\"1365\"\u003e4.3. Contraindications\u003c\/h4\u003e\n\u003cp data-start=\"1367\" data-end=\"1701\"\u003e• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1;\u003cbr data-start=\"1461\" data-end=\"1464\"\u003e• Hypersensitivity to local anesthetics or antihistamines;\u003cbr data-start=\"1522\" data-end=\"1525\"\u003e• Oozing or ulcerated skin lesions, wounds;\u003cbr data-start=\"1568\" data-end=\"1571\"\u003e• Acne;\u003cbr data-start=\"1578\" data-end=\"1581\"\u003e• Rosacea;\u003cbr data-start=\"1591\" data-end=\"1594\"\u003e• Bacterial, viral, fungal, or parasitic skin infections, even if accompanied by an inflammatory component.\u003c\/p\u003e\n\u003ch4 data-start=\"1703\" data-end=\"1753\"\u003e4.4. Special warnings and precautions for use\u003c\/h4\u003e\n\u003cp data-start=\"1755\" data-end=\"1845\"\u003e• This medicinal product contains \u003cstrong data-start=\"1789\" data-end=\"1809\"\u003epropylene glycol\u003c\/strong\u003e, which may cause skin irritation.\u003c\/p\u003e\n\u003cp data-start=\"1847\" data-end=\"1950\"\u003e• Pruritus is only a symptom and always requires investigation and treatment of its underlying cause.\u003c\/p\u003e\n\u003cp data-start=\"1952\" data-end=\"2057\"\u003e• Persistence or worsening of pruritus may be related to an allergy to one of the product’s components.\u003c\/p\u003e\n\u003cp data-start=\"2059\" data-end=\"2450\"\u003e• In the absence of data on cutaneous absorption, the risk of systemic effects cannot be excluded. This risk is increased when the product is used on large areas, under occlusive dressings, on damaged skin (especially burned skin), on mucous membranes, or on the skin of premature infants or infants (due to the surface\/weight ratio and the occlusive effect of diapers in the diaper area).\u003c\/p\u003e\n\u003cp data-start=\"2452\" data-end=\"2582\"\u003e• Athletes should be informed that this product contains an active substance that may result in a \u003cstrong data-start=\"2550\" data-end=\"2579\"\u003epositive anti-doping test\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp data-start=\"2584\" data-end=\"2618\"\u003e• Avoid application near the eyes.\u003c\/p\u003e\n\u003cp data-start=\"2620\" data-end=\"2644\"\u003e\u003cstrong data-start=\"2620\" data-end=\"2644\"\u003ePediatric population\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp data-start=\"2646\" data-end=\"2753\"\u003eIn children, application to the face should be limited due to the risk of accidental contact with the eyes.\u003c\/p\u003e\n\u003cp data-start=\"2755\" data-end=\"2778\"\u003e\u003cstrong data-start=\"2755\" data-end=\"2778\"\u003eVisual disturbances\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp data-start=\"2780\" data-end=\"3178\"\u003eVisual disturbances may occur with systemic or topical corticosteroid therapy. If blurred vision or any other visual symptom occurs during corticosteroid treatment, an ophthalmologic examination is required, particularly to investigate cataract, glaucoma, or rarer conditions such as central serous chorioretinopathy, which have been reported with corticosteroid use via systemic or topical routes.\u003c\/p\u003e\n\u003ch4 data-start=\"3180\" data-end=\"3262\"\u003e4.5. Interaction with other medicinal products and other forms of interaction\u003c\/h4\u003e\n\u003cp data-start=\"3264\" data-end=\"3307\"\u003eNo interaction studies have been conducted.\u003c\/p\u003e\n\u003ch4 data-start=\"3309\" data-end=\"3354\"\u003e4.6. Fertility, pregnancy, and lactation\u003c\/h4\u003e\n\u003cp data-start=\"3356\" data-end=\"3369\"\u003e\u003cstrong data-start=\"3356\" data-end=\"3369\"\u003ePregnancy\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp data-start=\"3371\" data-end=\"3446\"\u003eNo teratogenicity studies have been conducted with topical corticosteroids.\u003c\/p\u003e\n\u003cp data-start=\"3448\" data-end=\"3594\"\u003eHowever, studies involving oral corticosteroids have not demonstrated a higher risk of malformations than that observed in the general population.\u003c\/p\u003e\n\u003cp data-start=\"3596\" data-end=\"3678\"\u003eTherefore, this medicinal product may be prescribed during pregnancy if necessary.\u003c\/p\u003e\n\u003cp data-start=\"3680\" data-end=\"3697\"\u003e\u003cstrong data-start=\"3680\" data-end=\"3697\"\u003eBreastfeeding\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp data-start=\"3699\" data-end=\"3792\"\u003eDo not apply to the breasts during breastfeeding due to the risk of ingestion by the newborn.\u003c\/p\u003e\n\u003ch4 data-start=\"3794\" data-end=\"3848\"\u003e4.7. Effects on ability to drive and use machines\u003c\/h4\u003e\n\u003cp data-start=\"3850\" data-end=\"3865\"\u003eNot applicable.\u003c\/p\u003e\n\u003ch4 data-start=\"3867\" data-end=\"3896\"\u003e4.8. Undesirable effects\u003c\/h4\u003e\n\u003cp data-start=\"3898\" data-end=\"4028\"\u003eAs this medicinal product contains a \u003cstrong data-start=\"3935\" data-end=\"3979\"\u003elow-potency corticosteroid at a low dose\u003c\/strong\u003e, the adverse effects listed below are minimized.\u003c\/p\u003e\n\u003cp data-start=\"4030\" data-end=\"4233\"\u003e• Skin atrophy, telangiectasia (particularly a concern on the face), stretch marks (especially at the root of limbs and more commonly in adolescents), purpura secondary to skin atrophy, skin fragility;\u003c\/p\u003e\n\u003cp data-start=\"4235\" data-end=\"4301\"\u003e• Sensitization to mefenidramium methylsulfate and\/or lidocaine;\u003c\/p\u003e\n\u003cp data-start=\"4303\" data-end=\"4506\"\u003e• Mydriasis if applied near the eyes, particularly in children. This effect resolves spontaneously within 24 hours; rare ocular disorders have been reported, including blurred vision (see section 4.4);\u003c\/p\u003e\n\u003cp data-start=\"4508\" data-end=\"4566\"\u003e• Perioral dermatitis of the face; worsening of rosacea;\u003c\/p\u003e\n\u003cp data-start=\"4568\" data-end=\"4610\"\u003e• Delayed wound healing, depigmentation;\u003c\/p\u003e\n\u003cp data-start=\"4612\" data-end=\"4789\"\u003e• Secondary infections, particularly under occlusive dressings or in skin folds, and allergic contact dermatitis have also been reported with the use of topical corticosteroids.\u003c\/p\u003e\n\u003cp data-start=\"4791\" data-end=\"4835\"\u003e\u003cstrong data-start=\"4791\" data-end=\"4835\"\u003eReporting of suspected adverse reactions\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp data-start=\"4837\" data-end=\"5291\"\u003eReporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit\/risk balance. Healthcare professionals should report any suspected adverse reactions via the national reporting system: \u003cstrong data-start=\"5101\" data-end=\"5182\"\u003eFrench National Agency for the Safety of Medicines and Health Products (ANSM)\u003c\/strong\u003e and the network of Regional Pharmacovigilance Centers – website:\u003cbr data-start=\"5247\" data-end=\"5250\"\u003e\u003ca data-start=\"5250\" data-end=\"5291\" rel=\"noopener\" class=\"decorated-link\" href=\"https:\/\/signalement.social-sante.gouv.fr\/\"\u003ehttps:\/\/signalement.social-sante.gouv.fr\/\u003cspan aria-hidden=\"true\" class=\"ms-0.5 inline-block align-middle leading-none\"\u003e\u003csvg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"20\" height=\"20\" aria-hidden=\"true\" data-rtl-flip=\"\" class=\"block h-[0.75em] w-[0.75em] stroke-current stroke-[0.75]\"\u003e\u003cuse fill=\"currentColor\" href=\"\/cdn\/assets\/sprites-core-i9agxugi.svg#304883\"\u003e\u003c\/use\u003e\u003c\/svg\u003e\u003c\/span\u003e\u003c\/a\u003e\u003c\/p\u003e\n\u003ch4 data-start=\"5293\" data-end=\"5311\"\u003e4.9. Overdose\u003c\/h4\u003e\n\u003cp data-start=\"5313\" data-end=\"5328\"\u003eNot applicable.\u003c\/p\u003e\n\u003ch3 data-start=\"5330\" data-end=\"5363\"\u003e5. PHARMACOLOGICAL PROPERTIES\u003c\/h3\u003e\n\u003ch4 data-start=\"5365\" data-end=\"5401\"\u003e5.1. Pharmacodynamic properties\u003c\/h4\u003e\n\u003cp data-start=\"5403\" data-end=\"5521\"\u003ePharmacotherapeutic group: \u003cstrong data-start=\"5430\" data-end=\"5481\"\u003eLOW-POTENCY CORTICOSTEROID \/ TOPICAL ANESTHETIC\u003c\/strong\u003e,\u003cbr data-start=\"5482\" data-end=\"5485\"\u003eATC code: \u003cstrong data-start=\"5495\" data-end=\"5506\"\u003eD04AB01\u003c\/strong\u003e (Dermatology).\u003c\/p\u003e\n\u003cp data-start=\"5523\" data-end=\"5681\"\u003eCombination of a low-potency topical corticosteroid (hydrocortisone), a local antihistamine (mefenidramium methylsulfate), and a local anesthetic (lidocaine).\u003c\/p\u003e\n\u003ch4 data-start=\"5683\" data-end=\"5719\"\u003e5.2. Pharmacokinetic properties\u003c\/h4\u003e\n\u003cp data-start=\"5721\" data-end=\"5925\"\u003eThe extent of transdermal absorption and systemic effects depends on the size of the treated area, the degree of epidermal damage, and the duration of treatment. These effects increase with prolonged use.\u003c\/p\u003e\n\u003ch4 data-start=\"5927\" data-end=\"5960\"\u003e5.3. Preclinical safety data\u003c\/h4\u003e\n\u003cp data-start=\"5962\" data-end=\"5977\"\u003eNot applicable.\u003c\/p\u003e\n\u003ch3 data-start=\"5979\" data-end=\"6012\"\u003e6. PHARMACEUTICAL PARTICULARS\u003c\/h3\u003e\n\u003ch4 data-start=\"6014\" data-end=\"6042\"\u003e6.1. List of excipients\u003c\/h4\u003e\n\u003cp data-start=\"6044\" data-end=\"6172\"\u003eNon-ionic emulsifying wax with cetomacrogol 1000 (Lanol CTO® wax), diethylene glycol stearate, propylene glycol, purified water.\u003c\/p\u003e\n\u003ch4 data-start=\"6174\" data-end=\"6201\"\u003e6.2. Incompatibilities\u003c\/h4\u003e\n\u003cp data-start=\"6203\" data-end=\"6218\"\u003eNot applicable.\u003c\/p\u003e\n\u003ch4 data-start=\"6220\" data-end=\"6240\"\u003e6.3. Shelf life\u003c\/h4\u003e\n\u003cp data-start=\"6242\" data-end=\"6252\"\u003e30 months.\u003c\/p\u003e\n\u003ch4 data-start=\"6254\" data-end=\"6295\"\u003e6.4. Special precautions for storage\u003c\/h4\u003e\n\u003cp data-start=\"6297\" data-end=\"6350\"\u003eStore at a temperature \u003cstrong data-start=\"6320\" data-end=\"6349\"\u003enot exceeding 25°C (77°F)\u003c\/strong\u003e.\u003c\/p\u003e\n\u003ch4 data-start=\"6352\" data-end=\"6394\"\u003e6.5. Nature and contents of container\u003c\/h4\u003e\n\u003cp data-start=\"6396\" data-end=\"6509\"\u003eSealed \u003cstrong data-start=\"6403\" data-end=\"6425\"\u003e30 g aluminum tube\u003c\/strong\u003e, internally coated with epoxy-phenolic varnish and closed with a polypropylene cap.\u003c\/p\u003e\n\u003ch4 data-start=\"6511\" data-end=\"6566\"\u003e6.6. Special precautions for disposal and handling\u003c\/h4\u003e\n\u003cp data-start=\"6568\" data-end=\"6592\"\u003eNo special requirements.\u003c\/p\u003e\n\u003ch3 data-start=\"6594\" data-end=\"6631\"\u003e7. MARKETING AUTHORIZATION HOLDER\u003c\/h3\u003e\n\u003cp data-start=\"6633\" data-end=\"6723\"\u003e\u003cstrong data-start=\"6633\" data-end=\"6661\"\u003eP\u0026amp;G HEALTH FRANCE S.A.S.\u003c\/strong\u003e\u003cbr data-start=\"6661\" data-end=\"6664\"\u003e163\/165, Quai Aulagnier\u003cbr data-start=\"6687\" data-end=\"6690\"\u003e92600 Asnières-sur-Seine\u003cbr data-start=\"6714\" data-end=\"6717\"\u003eFrance\u003c\/p\u003e\n\u003ch3 data-start=\"6725\" data-end=\"6765\"\u003e8. MARKETING AUTHORIZATION NUMBER(S)\u003c\/h3\u003e\n\u003cp data-start=\"6767\" data-end=\"6823\"\u003e• \u003cstrong data-start=\"6769\" data-end=\"6790\"\u003e34009 344 575 4 8\u003c\/strong\u003e: 30 g tube (varnished aluminum).\u003c\/p\u003e\n\u003ch3 data-start=\"6825\" data-end=\"6886\"\u003e9. DATE OF FIRST AUTHORIZATION \/ RENEWAL OF AUTHORIZATION\u003c\/h3\u003e\n\u003cp data-start=\"6888\" data-end=\"6939\"\u003e[To be completed later by the authorization holder]\u003c\/p\u003e\n\u003ch3 data-start=\"6941\" data-end=\"6977\"\u003e10. DATE OF REVISION OF THE TEXT\u003c\/h3\u003e\n\u003cp data-start=\"6979\" data-end=\"7030\"\u003e[To be completed later by the authorization holder]\u003c\/p\u003e\n\u003ch3 data-start=\"7032\" data-end=\"7049\"\u003e11. DOSIMETRY\u003c\/h3\u003e\n\u003cp data-start=\"7051\" data-end=\"7066\"\u003eNot applicable.\u003c\/p\u003e\n\u003ch3 data-start=\"7068\" data-end=\"7128\"\u003e12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS\u003c\/h3\u003e\n\u003cp data-start=\"7130\" data-end=\"7145\"\u003eNot applicable.\u003c\/p\u003e\n\u003chr data-start=\"7147\" data-end=\"7150\"\u003e\n\u003ch3 data-start=\"7152\" data-end=\"7193\"\u003eCONDITIONS OF PRESCRIPTION AND SUPPLY\u003c\/h3\u003e\n\u003cp data-start=\"7195\" data-end=\"7245\"\u003e\u003cstrong data-start=\"7195\" data-end=\"7245\"\u003eMedicinal product not subject to prescription.\u003c\/strong\u003e\u003c\/p\u003e","brand":"Pharmarcie.com","offers":[{"title":"Default Title","offer_id":45200450715820,"sku":"P3400934457548","price":29.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0604\/4047\/7868\/files\/Alist4_7acdc413-c642-4d04-9cb7-632b1c0fc349.png?v=1767371823","url":"https:\/\/pharmarcie.com\/products\/onctose-hydrocortisone-anti-itch-cream-30-g","provider":"Pharmarcie.com","version":"1.0","type":"link"}