Label: FOAMING CLEANSER JAFRA- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-096-01 - Packager: JAFRA COSMETICS INTERNATIONAL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 22, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Active Ingredient Purpose
Salicyclic Acid 0.5% Acne Treatment
keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
indications and usage
When using this product
Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
Directions
-Gently massage over face, rinse well and pat dry.
-Avoid contact with eyes.
-Because excessive drying of the skin may occur, start with
1 application daily, then gradually increase to 2 or 3
times daily if needed or as directed by a doctor.
-If bothersome dryness or peeling occurs, reduce application
to once a day or every other day.Inactive ingredients
Benzophenone-4, cocamidopropyl
Betaine, Decyl Glucoside, Diazolidinyl Urea, Disodium EDTA,
lodopropynyl Butylcarbamate, Fragrance/Parfum, Polysorbate
20, Propylene Glycol, Salix Nigra (Willow) Bark Extract, Sodium
C14-16 Olefin Sulfonate, Sodium Lauroyl Oat Amino Acids,
TEA-Cocoyl Glutamate, Water/Aqua. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FOAMING CLEANSER JAFRA
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-096 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength SULISOBENZONE (UNII: 1W6L629B4K) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) EDETATE DISODIUM (UNII: 7FLD91C86K) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SALIX NIGRA BARK (UNII: QU52J3A5B3) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-096-01 1 in 1 CARTON 05/15/2012 1 150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 05/15/2012 Labeler - JAFRA COSMETICS INTERNATIONAL (041676479) Registrant - JAFRA COSMETICS INTERNATIONAL (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-096)
