ACNE FIGHTING FOUNDATION by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD.

ACNE FIGHTING FOUNDATION by

Drug Labeling and Warnings

ACNE FIGHTING FOUNDATION by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai J. A. Cosmetics Trading CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACNE FIGHTING FOUNDATION- salicylic acid cream 
J. A. Cosmetics U.S. INC

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.

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Active Ingredient:

SALICYLIC ACID 2%

Purpose:

ACNE TREATMENT

Uses:

• FOR TREATMENT OF ACNE 
• HELPS PREVENT NEW ACNE BLEMISHES

Warning:

For external use only

When Using This Product

• KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
• WITH OTHER TROPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF SKIN. IF OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Stop use and ask a doctor if

• rash occurs.

KEEP OUT OF REACH OF CHILDREN.

Directions:

• CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICATION. COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY. BEACAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THE GRADUALLY INCREASE TO TWO OR THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. IF BOTHERSOME DRYNESSOR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.

Inactive Ingredient:

WATER (AQUA), CYCLOPENTASILOXANE, HYDROGENATED POLYISBUTENE, ETHOXYDIGLYCOL, DIMETHICONE, CYCLOHEXASILOXANE, DIMETHICONE CROSSPOLYMER, PEG-10 DIMETHICONE, DIMETHICONE/PEG-10/15 CROSSPLOYMER, PROPYLENE GLYCOL, NYLON-12, TALC, PHENOXYETHANOL, QUATERNIUM 18 BENTONITE, MAGNESIUM SULFATE, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, CINNAMOMUM CAMPHORA (CAMPHOR) BARK OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, ALOE BARBADENSIS LEAF JUICE, HEXAPEPTIDE-9, HAMAMELIS VIRGINIANA (WHICH HAZEL) WATER

MAY CONTAIN: IRON OXIDES (CL 77491, CL 77492, CL 77499) TIANIUM DIOXIDE (CL 77891)

ACNE FIGHTING FOUNDATION 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-203
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
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
NYLON-12 (UNII: 446U8J075B)
TALC (UNII: 7SEV7J4R1U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENTOQUATAM (UNII: 7F465U79Q1)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
CINNAMOMUM CAMPHORA WHOLE (UNII: 0B27814T7X)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-203-51	1 in 1 BOX	02/02/2014	12/31/2017
1	NDC: 76354-203-11	36 mL in 1 TUBE; 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	02/02/2014	12/31/2017

Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 3/2014

Document Id: cc403a3b-c128-4cd8-befe-d741f6dc4150

34390-5

Set id: 9146bf2b-7257-4e64-829b-4b6fac19640d

Version: 4

Effective Time: 20140319

 

J. A. Cosmetics U.S. INC