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

ACNE FIGHTING by

Drug Labeling and Warnings

ACNE FIGHTING 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- salicylic acid gel 
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.

----------

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.
• USING OTHER TROPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF SKIN. IF THIS 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. BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN 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), ALCOHOL DENAT., HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, CINNAMUM CAMPHORA (CAMPHOR) BARK OIL, SODIUM BENZOATE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, CAMELLIA SINENSIS LEAF EXTRACT, BUTYLENE GLYCOL, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

OTHER INFORMATION

• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

ACNE FIGHTING 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-209
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
WITCH HAZEL (UNII: 101I4J0U34)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
CAMPHOR OIL (UNII: 75IZZ8Y727)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TEA TREE OIL (UNII: VIF565UC2G)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-209-51	1 in 1 BOX	01/27/2015	12/31/2017
1	NDC: 76354-209-11	6 mL in 1 BOTTLE; 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	01/27/2015	12/31/2017

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

Revised: 1/2015

Document Id: 8684c514-cecf-46f2-9fbf-80b21f7f1609

34390-5

Set id: be006096-f041-4f6d-82bc-0a84402095ac

Version: 2

Effective Time: 20150115

 

J. A. Cosmetics U.S. INC