COOPER STERILISED PETROLATUM Jar 20g

Petroleum jelly............................................................................................................................................................100 g

For 100 g of sterile ointment

Adjunctive treatment of irritation and skin dryness lesions.

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 on the areas to be treated

• Hypersensitivity to the active substance

• Infected dermatosis.

• Use of latex condoms (see section Interactions).

For external use.

Do not swallow.

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.

Given the available data, use in pregnant or breastfeeding women is possible. Do not apply to the breasts during breastfeeding.

Possible hypersensitivity reactions.

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.

Pharmacotherapeutic class: SKIN PROTECTANT (D. Dermatology) ATC code: D02AC

Emollient ointment.

Mechanism of action

In cases of dry skin, application of petrolatum helps repair the skin barrier and increase its water content by reducing transepidermal water loss. The skin barrier's capacity to retain and redistribute water is thus restored

Petrolatum is a mixture of long-chain saturated aliphatic hydrocarbons that is not absorbed through the skin

Acute toxicity assessed in rats and rabbits by oral and topical administration is very low, with LD50 values greater than 2000 mg/kg.

Animal studies show that chronic daily application of pharmaceutical-grade petrolatum is well tolerated; no systemic toxicity was observed. The only target organ identified is the skin, with the presence of moderate dermatitis. The reversibility of this effect was not evaluated.

Pharmaceutical-grade petrolatum is neither mutagenic nor genotoxic in vitro, in bacteria and mammalian cells, and in vivo in rats.

Pharmaceutical-grade petrolatum is not carcinogenic.

Pharmaceutical-grade petrolatum does not cross the skin barrier; the risk of inducing a reproductive toxic effect after cutaneous application is therefore nil. No effect on fertility and reproduction was demonstrated in rats up to the dose of 1000 mg/kg/day. Given the absence of passage through the skin, exposure of breastfeeding women to the product is negligible and no effect in the infant is expected.

Pharmaceutical-grade petrolatum may induce skin irritation after repeated application; it is not considered potentially sensitizing, but very rare cases of sensitization have been reported in humans. Phototoxicity/photosensitization was not evaluated.

5 years.

No special precautions for storage.

No special requirements.