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

ZIT ZAPPER by

Drug Labeling and Warnings

ZIT ZAPPER 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 ZAPPER- 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, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, CINNAMOMUM CAMPHORA (CAMPHOR) BARK OIL, SODIUM BENZOATE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, CAMELLIA SINESSIS LEAF EXTRACT, BUTYLENE GLYCOL, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

ZIT ZAPPER 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-202
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)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
CINNAMOMUM CAMPHORA WHOLE (UNII: 0B27814T7X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-202-51	1 in 1 BOX	10/10/2013	12/31/2017
1	NDC: 76354-202-11	30 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: 4/2014

Document Id: 773c4005-e058-4499-8171-2475ed3de8bd

34390-5

Set id: 40713e7e-58b8-4319-ab8d-5fcdebef7ee4

Version: 5

Effective Time: 20140408