ELF Zit Zapper by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD. Drug Fact

ELF Zit Zapper by

Drug Labeling and Warnings

ELF 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]

ELF ZIT ZAPPER - salicylic acid liquid 
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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Drug Fact

Active Ingredient:

Salicylic Acid 1.0%

Purpose:

Acne Treatment

Uses:

For the 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 topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Stop Use and Ask A Doctor If:

Rash or irritation develops and lasts

Keep Out of Reach of Children:

If swallowed get medical help or contact a Poison Control Center immediately

Directions:

Cleanse skin thoroughly before applying medication. Cover the entire affected area by a thin layer one to three times daily. Because excessive drying of skin may occur, start with one application daily, then gradually increase to two or three time daily, if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once daily or every other day.

Other Information:

Store at room temperature 20-25C (68-77F)

Inactive Ingredient:

Water, Witch Hazel (Hamamelis Virginiana) Distillate, Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Cinnamomum Camphora (Camphor) Bark Oil

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ELF ZIT ZAPPER 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	86.70 g  in 100 g
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
ALCOHOL (UNII: 3K9958V90M)
TEA TREE OIL (UNII: VIF565UC2G)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
CAMPHOR OIL (UNII: 75IZZ8Y727)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-003-01	6 g in 1 TUBE; Type 0: Not a Combination Product	10/09/2011	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	10/09/2011	12/31/2017

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

Revised: 4/2012

Document Id: 1fe784e6-d061-4bc3-ae21-f1b2d16dc908

34390-5

Set id: c6389754-e170-418c-ac50-b3a92fbec971

Version: 3

Effective Time: 20120418

 

J. A. Cosmetics U.S. INC