ZIT ERASER by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD.

ZIT ERASER by

Drug Labeling and Warnings

ZIT ERASER 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]

ZIT ERASER- 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 1%

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 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.

Other Information

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

Inactive Ingredient:

WATER (AQUA), ALCOHOL DENAT, HAMAMELIS VIRGINANA (WHICH HAZEL) WATER, HYDROXYETHYLCELLULOSE, SODIUM BENZOATE, CAMPHOR, HYDROLYZED COLLAGEN, BUTYLENE GLYCOL, ALOE ARBORESCENS LEAF EXTRACT, CAMELLIA SINESSIS LEAF EXTRACT, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

ZIT ERASER 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-206
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CAMPHOR OIL (UNII: 75IZZ8Y727)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-206-51	1 in 1 BOX	10/10/2013	12/31/2017
1	NDC: 76354-206-11	3.5 g 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	10/10/2013	12/31/2017

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

Revised: 5/2014

Document Id: c64f8126-a416-490c-8d74-ac9d3ddc35af

34390-5

Set id: f54e0652-4ce3-4718-9817-bff9be348d88

Version: 3

Effective Time: 20140521

 

J. A. Cosmetics U.S. INC