BIAFINE Emulsion for cutaneous application Ref.[51155] Active ingredients: Trolamine

Source: Medicines Authority (MT) Revision Year: 2023 Publisher: JOHNSON & JOHNSON Santé Beauté France, 1, RUE CAMILLE DESMOULINS, 92130 ISSY-LES-MOULINEAUX, FRANCE

Product name and form

BIAFINE, emulsion for cutaneous application.

Pharmaceutical Form
Emulsion for cutaneous application.

Qualitative and quantitative composition

TROLAMINE 0.670 g.

Per 100 g of emulsion for cutaneous application.

Excipients with known effect: Propylene glycol, Potassium sorbate, Sodium methyl parahydroxybenzoate (E219), Sodium propyl parahydroxybenzoate (E217); Yerbatone fragrance.

For the complete list of excipients, see 6.1.

Active Ingredient	Description
Trolamine

List of Excipients
Ethylene glycol monostearate, Stearic acid, Cetyl palmitate, Solid paraffin, Liquid paraffin, Perhydrosqualene, Propylene glycol, Avocado oil, Trolamine and sodium alginate, Potassium sorbate (quantity expressed as sorbic acid), Sodium methyl parahydroxybenzoate (E 219), Sodium propyl parahydroxybenzoate (E217), Yerbatone fragrance, Purified water. ^ Composition of the Yerbatone fragrance: deterpenated essential oil of orange, deterpenated essential oil of galbanum, deterpenated essential essential oil of petitgrain, essential oil of lemongrass, celestolide, paratertiobutyl cyclohexyl acetate, hexyl cinnamaldehyde, citral, limonene, phenylethyl alcohol, traseolide, hercolyn, phenylethyl acetate, methylionone, dipropylene glycol, methyl dihydrojasmonate.

Pack sizes and marketing

Aluminium tube containing, 93g internally coated by an epoxyphenolic coating and closed by a high-density polyethylene cap.

Marketing authorization holder

JOHNSON & JOHNSON Santé Beauté France, 1, RUE CAMILLE DESMOULINS, 92130 ISSY-LES-MOULINEAUX, FRANCE

Marketing authorization dates and numbers

MA065/00101

Date of first authorisation: 2^nd March 2007
Date of last renewal: 1^st March 2012

Drugs

Drug	Countries
BIAFINE	Ecuador, France, Israel, Malta, Tunisia

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