OIL FREE ACNE WASH- salicylic acid 2.00% cream

Oil Free Acne Wash by

Drug Labeling and Warnings

Oil Free Acne Wash by is a Otc medication manufactured, distributed, or labeled by Topco, Product Quest. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                    Purpose

Salicylic acid 2%..................... Acne treatment

PURPOSE

INDICATIONS & USAGE

Use for the treatment of acne

WarningsFor external use only

When using  other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

DOSAGE & ADMINISTRATION

Directions wet face apply to hands and work into a lather massage face gently rinse thoroughly and pat dry cleanse twice a day.

INACTIVE INGREDIENT

Inactive ingredients: Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Cetyl Alcohol, Stearyl Alcohol, Di-C12-15 Alkyl Fumarate, Coco-Glucoside, Coconut Alcohol, Sodium Methyl Cocoyl Taurate, DEA-Cetyl Phosphate, Matriciaria (Chamomilla Recutita) Flower Extract, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Extract, Hydroxypropyl Methylcellulose, Potato (Solanum Tuberosum) Starch, Propylene Glycol, Fragrance.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OIL FREE ACNE WASH 
salicylic acid 2.00% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-743
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Salicylic Acid	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Cetyl Alcohol (UNII: 936JST6JCN)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Di-C12-15 Alkyl Fumarate (UNII: A1CB3Z898P)
COCO GLUCOSIDE (UNII: ICS790225B)
Coconut Alcohol (UNII: 13F4MW8Y9K)
Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
CHAMOMILE (UNII: FGL3685T2X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STARCH, POTATO (UNII: 8I089SAH3T)
Propylene Glycol (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-743-05	198 mL in 1 TUBE; Type 0: Not a Combination Product	11/17/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/17/2011

Labeler - Topco (006935977)

Registrant - Product Quest (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest		927768135	manufacture(36800-743) , label(36800-743)