Viatris Glycerol, Vaseline & Paraffin Moisturizing Cream – 250 g

Moisturizing and protective care for dry skin

Viatris Glycerol, Vaseline & Paraffin Cream is an emollient skin protectant that helps hydrate dry skin and restore its protective barrier. It helps reduce itching and irritation associated with dryness, leaving skin softer and more comfortable.

This medicinal cream is used as a supportive treatment for skin dryness associated with atopic dermatitis, ichthyosis and psoriasis. It is also indicated as a supportive treatment for small, superficial burns.

Suitable for adults, children and full-term infants.

How It Works

• Glycerol 15%: Increases hydration to help soften dry skin.

• Vaseline 8%: Helps restore the skin’s protective barrier.

• Liquid paraffin 2%: Works with vaseline to limit moisture loss and maintain hydration.

Directions for Use

Apply a thin layer to the affected areas once or twice daily, or more frequently if necessary. Follow the package leaflet or the advice of your doctor or pharmacist.

For external use only. Do not swallow.

Ingredients

Active ingredients per 100 g:

• Glycerol: 15 g

• Vaseline (petrolatum): 8 g

• Liquid paraffin: 2 g

Other ingredients: Stearic acid, glycerol monostearate, cyclomethicone, dimethicone, macrogol 600, propyl parahydroxybenzoate (E216), trolamine and purified water.

Precautions

• Do not use if you are allergic to any ingredient.

• Contains propyl parahydroxybenzoate, which may cause allergic reactions, including delayed reactions.

• Do not apply to infected skin lesions or beneath an airtight dressing.

• Do not use on premature infants.

• Ask your doctor or pharmacist for advice before use during pregnancy or breastfeeding. Do not apply to the breasts while breastfeeding.

• Consult a doctor if symptoms worsen or have not improved after 30 days.

• Keep out of the sight and reach of children.

Storage

Use within six months of opening and before the expiry date printed on the tube.

Brand: Viatris
Size: 250 g tube
Barcode / CIP: 3400927835841

PLEASE READ THE FOLLOWING FULL DISCLOSURE BEFORE PURCHASING OR USING THIS PRODUCT

SUMMARY OF PRODUCT CHARACTERISTICS ANSM - Last updated: 25/09/2026 1. NAME OF THE MEDICINAL PRODUCT GLYCEROL/VASELINE/PARAFFINE VIATRIS 15%/8%/2%, cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Glycerol............................................................................................................................. 15.000 g Petrolatum............................................................................................................................ 8.000 g Liquid paraffin..................................................................................................................... 2.000 g Per 100 g. Excipient with known effect: propyl parahydroxybenzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Rich white cream. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Adjunctive treatment of dry skin associated with certain skin conditions, such as atopic dermatitis, ichthyosis and psoriasis, in adults and children, including infants. Adjunctive treatment of small superficial burns. 4.2. Posology and method of administration Posology In adults and children, including infants, apply a thin layer of cream to the areas to be treated once or twice daily, or more frequently if necessary. Paediatric population The safety and efficacy of GLYCEROL/VASELINE/PARAFFINE VIATRIS have not been established in premature infants. Method of administration Cutaneous use 4.3. Contraindications Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 4.4. Special warnings and precautions for use Do not swallow. Application to infected lesions or under an occlusive dressing is not recommended. This medicinal product contains propyl parahydroxybenzoate and may cause allergic reactions (possibly delayed). 4.5. Interaction with other medicinal products and other forms of interaction No interaction studies have been performed. 4.6. Fertility, pregnancy and lactation Pregnancy No effects on pregnancy are anticipated, as systemic exposure to glycerol, petrolatum and paraffin is negligible. GLYCEROL/VASELINE/PARAFFINE VIATRIS may be used during pregnancy. Breastfeeding No effects on the breastfed newborn/infant are anticipated, as systemic exposure of the breastfeeding mother to glycerol, petrolatum and paraffin is negligible. GLYCEROL/VASELINE/PARAFFINE VIATRIS may be used during breastfeeding. The only recommendation is to avoid applying GLYCEROL/VASELINE/PARAFFINE VIATRIS to the breasts during breastfeeding. Fertility No effects on fertility are anticipated, as systemic exposure to glycerol, petrolatum and paraffin is negligible. 4.7. Effects on ability to drive and use machines GLYCEROL/VASELINE/PARAFFINE VIATRIS has no or negligible influence on the ability to drive and use machines. 4.8. Undesirable effects Adverse reactions are classified below according to the MedDRA database by System Organ Class and frequency, using the following convention: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data). The following adverse reactions have been reported during clinical studies and since this medicinal product was first marketed: System Organ Class Adverse reactions by frequency Uncommon Frequency not known Skin and subcutaneous tissue disorders Urticaria, dermatitis, eczema, erythema, pruritus, rash Skin burning sensation General disorders and administration site conditions Application site reactions* Application site eczema * irritation, redness, pain or itching at the application site Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse reactions via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/. 4.9. Overdose No cases of overdose have been reported. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic properties Pharmacotherapeutic group: EMOLLIENT and SKIN PROTECTANT, ATC code: D02AC. Emollient and moisturising cream. The mechanisms of action of this medicinal product are as follows: · reduction of insensible water loss from the skin: petrolatum and paraffin form a lipid layer that limits water loss from the stratum corneum and helps retain water-soluble and hygroscopic substances within it; · increased hydration of the superficial layers of the skin due to the hygroscopic properties of glycerol and its penetration into the epidermis. The skin-protective effect has also been demonstrated by ex vivo tests performed on delipidated tissue implants. These tests showed rapid restructuring of the lipid barrier, demonstrating the emollient activity of the glycerol/petrolatum/paraffin combination, involving restoration of the homeostasis of corneodesmosomal junctions. An ex vivo study performed on isolated human stratum corneum showed an improvement in the content of ceramides, lipid components of the stratum corneum. These properties, demonstrated in pharmacoclinical studies using validated models, help restore the skin's hydration and barrier function, thereby helping to reduce irritation, pruritus and scratching. Clinical studies involving conditions characterised by dry skin, such as ichthyosis or atopic dermatitis in children, have confirmed these properties: · Ichthyosis: a double-blind, placebo-controlled study lasting 28 days, followed by a 2-month open-label period. The glycerol/petrolatum/paraffin combination significantly improves symptoms assessed using the SRRC score (Scaling, Roughness, Redness, Cracks/fissures): 65% of patients responded to this medicinal product, compared with 50% receiving the vehicle, with response defined as a reduction in the SRRC score of at least 50%. The reduction in the SRRC score and pruritus was significantly greater (p < 0.05) on days 14 and 28 in patients treated with the glycerol/petrolatum/paraffin combination compared with the placebo group (double-blind period). During the open-label period, a significant reduction (p < 0.01) in the SRRC score and pruritus was observed up to day 84 in patients treated with the glycerol/petrolatum/paraffin combination. · Atopic dermatitis in children: a double-blind, placebo-controlled study lasting 28 days, followed by a 2-month open-label period, with reintroduction of the glycerol/petrolatum/paraffin combination in patients who relapsed on day 56. The glycerol/petrolatum/paraffin combination significantly improves skin dryness in patients with moderate to severe xerosis (glycerol/petrolatum/paraffin combination 43% versus placebo 29%, p < 0.001) during the double-blind period (days 1 to 28). A significant improvement in atopic dermatitis in patients with moderate to severe xerosis is observed as early as day 7. The observed difference in xerosis increases over time from day 7 to day 28. When the glycerol/petrolatum/paraffin combination is applied to xerotic skin, the hydration index measured using a corneometer reaches normal hydration values (> 40 corneometer units) by day 28. The results observed during the open-label period (days 29 to 84) show that, in responders, discontinuation of the emollient leads to a recurrence of xerosis and, in non-responders, initiation or continuation of emollient treatment after day 28 leads to an improvement in xerosis. The results of these clinical studies demonstrate the benefit of long-term treatment with the glycerol/petrolatum/paraffin combination: · in responders, discontinuation of treatment leads to worsening of xerosis and the underlying skin condition; · resumption of treatment leads to an improvement in xerosis and the underlying skin condition. 5.2. Pharmacokinetic properties Not applicable. 5.3. Preclinical safety data Preclinical data show good skin tolerability of this medicinal product, which has also been confirmed in humans. The cream has been shown to be non-irritating to the eyes. It has no phototoxic potential and shows low sensitising and photosensitising potential in animals, but the risk is considered negligible in humans because there is no UV absorption beyond 290 nm. 6. PHARMACEUTICAL PARTICULARS 6.1. List of excipients Stearic acid, glycerol monostearate, cyclomethicone, dimethicone, macrogol 600, propyl parahydroxybenzoate (E216), trolamine, purified water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 21 months After first opening the tube: 6 months. 6.4. Special precautions for storage This medicinal product does not require any special storage conditions. 6.5. Nature and contents of container 250 g in a polyethylene (PE) tube closed with a polypropylene (PP) cap. 6.6. Special precautions for disposal and other handling No special requirements. 7. MARKETING AUTHORISATION HOLDER VIATRIS SANTE 1 RUE DE TURIN 69007 LYON 8. MARKETING AUTHORISATION NUMBER(S) · 34009 278 358 4 1: 250 g in a tube (PE) closed with a cap (PP). 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [to be completed subsequently by the marketing authorisation holder] <Date of first authorisation: {DD month YYYY}> 10. DATE OF REVISION OF THE TEXT [to be completed subsequently by the marketing authorisation holder] <{DD month YYYY}> 11. DOSIMETRY Not applicable. 12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS Not applicable. PRESCRIPTION AND SUPPLY CONDITIONS Medicinal product not subject to medical prescription.