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.

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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.
  • 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 Gel_card backAcne Fighting Gel_card front

Acne Fighting Gel_tube

ACNE FIGHTING 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76354-209
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76354-209-511 in 1 BOX01/27/201512/31/2017
1NDC: 76354-209-116 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/27/201512/31/2017
Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 1/2015
 
J. A. Cosmetics U.S. INC