FOAMING CLEANSER JAFRA- salicylic acid gel

Foaming Cleanser by

Drug Labeling and Warnings

Foaming Cleanser by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient                  Purpose

Salicyclic Acid 0.5%              Acne Treatment

Uses

 Treats acne   

 Prevents new acne pimples

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.

Warnings

For external use only

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

Jafra

Foaming Cleanser

Espuma Facial Limpiadora

150 ml  4.5 Fl Oz

INGREDIENTS AND APPEARANCE

FOAMING CLEANSER  JAFRA
salicylic acid gel

Product 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)