Medicines
SmPC of the 15/02/2024
VASELINE OFFICINALE COOPER, ointment
Composition
Petroleum jelly............................................................................................................................................................100 g
For 100 g of ointment.
Dosage and administration
Dosage
2 to 3 applications per day to the affected areas.
Method of administration
Cutaneous route
Apply the ointment by gently massaging in a thin layer onto the areas to be treated.
The duration of treatment is limited to 7 days.
In the absence of improvement or in case of worsening of irritation and skin dryness lesions after 7 days of use, medical advice is necessary.
Contraindications
• Hypersensitivity to the active substance
• Infected dermatosis.
• Use of latex condoms (see section Interactions).
Warnings and precautions
Do not swallow. Avoid repeated use over large surfaces, under occlusive dressing as occlusion promotes superinfection.
Do not apply to ulcerated, infected or weeping skin lesions, including acne or rosacea lesions.
Do not apply other dermatological products to the treated surface.
Do not increase the frequency of applications.
If irritation persists beyond 7 days, as well as in case of local intolerance or skin superinfection, treatment must be stopped and the course of action reassessed.
Interactions
Contraindicated combinations
Latex condoms:
Risk of condom breakage when used with fatty substances or lubricants containing mineral oils (paraffin oil, silicone oil, etc.). Use a water-soluble lubricant.
Fertility, pregnancy and breastfeeding
Given the available data, use in pregnant or breastfeeding women is possible. Do not apply to the breasts during breastfeeding.
Adverse effects
Possible hypersensitivity reactions.
Cases of lip edema have been reported following use of petroleum jelly on the lips after dental surgery.
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 are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
Pharmacodynamics
Pharmacotherapeutic class: SKIN PROTECTANT (D. Dermatology), ATC code: D02AC.
Emollient ointment.
Mechanism of action
In cases of skin dryness, application of petroleum jelly repairs the skin barrier and increases its water content by reducing transepidermal water loss. The ability of the skin barrier to retain and redistribute water is thus restored.
Pharmacokinetics
Petroleum jelly is a mixture of saturated long-chain aliphatic hydrocarbons that is not absorbed through the skin.
Preclinical safety
Studies in animals (rats and mice) have shown that petroleum jelly is non-toxic and non-carcinogenic.
Prescription, supply and reimbursement
| Marketing authorisation (AMM) |
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PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Tel: 01 64 87 20 00 https://www.cooper.fr/
Source: VIDAL · Updated on 10/11/2026. This information does not replace advice from a healthcare professional.
