Onctose Hydrocortisone – Anti-Itch Cream (30 g)

Product overview

Onctose Hydrocortisone is an anti-itch cream combining:

• a mild topical corticosteroid (hydrocortisone acetate),

• an antihistamine (mepyramine/mefenidramium derivative),

• and a local anesthetic (lidocaine)

It’s mainly used to relieve itching, especially from insect bites/stings.

Who it’s for

• Adults, adolescents, children ≥ 30 months

• Pregnancy: only with medical advice

• Breastfeeding: only with medical advice (do not apply on breasts)

Indications

• Itching / pruritus, especially from insect bites

Directions (how to use)

• Skin use only

• Apply 1 application, 2–3 times per day

• Wash hands after use

• Max duration: 3 days

• If itching persists beyond 3 days, consult a doctor.

Do NOT use / Avoid

Do not apply:

• on large areas

• under occlusive dressing (including diaper area / under a layer that “seals” the skin)

• near the eyes

• on mucous membranes (including intimate areas)

Do not use if:

• allergy to local anesthetics, antihistamines, or hydrocortisone

• infected skin of any kind (viral, bacterial, fungal): acne, rosacea, mycosis, etc.

• weeping/oozing or ulcerated lesions

Children

• Contraindicated under 30 months

• Over 30 months: allowed, except not on the face

Possible side effects (key ones)

• Allergic skin reaction

• With prolonged use: skin thinning, stretch marks, acne-like eruptions, irritation/redness, pigment changes, delayed healing, secondary skin infections

• Vision problems if applied in/near the eye

Athletes (doping note)

Contains an active ingredient that may trigger a positive anti-doping test.

Composition (actives per 100 g)

• Hydrocortisone acetate 0.250 g

• Lidocaine HCl 1.000 g

• Mefenidramium methylsulfate 2.000 g

Pack size

• Tube 30 g

Please read the following full disclosure before purchasing or using this product. 

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM – Last updated: 29/08/2023

1. NAME OF THE MEDICINAL PRODUCT

ONCTOSE HYDROCORTISONE, cream

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Hydrocortisone acetate .............................................................. 0.250 g
Lidocaine hydrochloride .............................................................. 1.000 g
Mefenidramium methylsulfate ..................................................... 2.000 g

Per 100 g of cream

Excipient with known effect: propylene glycol.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cream.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

Local symptomatic treatment of pruritus (itching), particularly following insect bites.

4.2. Posology and method of administration

Dosage

1 application 2 to 3 times daily.

Increasing the number of applications may worsen adverse effects without improving therapeutic benefit.

Treatment duration is limited to 3 days.

Method of administration

Cutaneous use only.

Wash hands thoroughly after each application.

4.3. Contraindications

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1;
• Hypersensitivity to local anesthetics or antihistamines;
• Oozing or ulcerated skin lesions, wounds;
• Acne;
• Rosacea;
• Bacterial, viral, fungal, or parasitic skin infections, even if accompanied by an inflammatory component.

4.4. Special warnings and precautions for use

• This medicinal product contains propylene glycol, which may cause skin irritation.

• Pruritus is only a symptom and always requires investigation and treatment of its underlying cause.

• Persistence or worsening of pruritus may be related to an allergy to one of the product’s components.

• 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).

• Athletes should be informed that this product contains an active substance that may result in a positive anti-doping test.

• Avoid application near the eyes.

Pediatric population

In children, application to the face should be limited due to the risk of accidental contact with the eyes.

Visual disturbances

Visual 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.

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been conducted.

4.6. Fertility, pregnancy, and lactation

Pregnancy

No teratogenicity studies have been conducted with topical corticosteroids.

However, studies involving oral corticosteroids have not demonstrated a higher risk of malformations than that observed in the general population.

Therefore, this medicinal product may be prescribed during pregnancy if necessary.

Breastfeeding

Do not apply to the breasts during breastfeeding due to the risk of ingestion by the newborn.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

As this medicinal product contains a low-potency corticosteroid at a low dose, the adverse effects listed below are minimized.

• 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;

• Sensitization to mefenidramium methylsulfate and/or lidocaine;

• 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);

• Perioral dermatitis of the face; worsening of rosacea;

• Delayed wound healing, depigmentation;

• Secondary infections, particularly under occlusive dressings or in skin folds, and allergic contact dermatitis have also been reported with the use of topical corticosteroids.

Reporting of suspected adverse reactions

Reporting 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: French National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers – website:
https://signalement.social-sante.gouv.fr/

4.9. Overdose

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: LOW-POTENCY CORTICOSTEROID / TOPICAL ANESTHETIC,
ATC code: D04AB01 (Dermatology).

Combination of a low-potency topical corticosteroid (hydrocortisone), a local antihistamine (mefenidramium methylsulfate), and a local anesthetic (lidocaine).

5.2. Pharmacokinetic properties

The 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.

5.3. Preclinical safety data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Non-ionic emulsifying wax with cetomacrogol 1000 (Lanol CTO® wax), diethylene glycol stearate, propylene glycol, purified water.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

30 months.

6.4. Special precautions for storage

Store at a temperature not exceeding 25°C (77°F).

6.5. Nature and contents of container

Sealed 30 g aluminum tube, internally coated with epoxy-phenolic varnish and closed with a polypropylene cap.

6.6. Special precautions for disposal and handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

P&G HEALTH FRANCE S.A.S.
163/165, Quai Aulagnier
92600 Asnières-sur-Seine
France

8. MARKETING AUTHORIZATION NUMBER(S)

• 34009 344 575 4 8: 30 g tube (varnished aluminum).

9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION

[To be completed later by the authorization holder]

10. DATE OF REVISION OF THE TEXT

[To be completed later by the authorization holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

CONDITIONS OF PRESCRIPTION AND SUPPLY

Medicinal product not subject to prescription.