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

ELF Zit Eraser by

Drug Labeling and Warnings

ELF 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]

ELF ZIT ERASER - 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 tropical acne medications at the same time or immediately following use of this product may increase dryness or irritation to the skin.  If this occurs, only one medication should be used unless directed by your 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 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 dryness or peeling occurs, reduce application to once a day or every other day.

Other Information:

Protect the product in its container from excessive heat and direct heat.

Inactive Ingredient:

Water (Aqua), Alcohol Denature, Hydroxyethylcellulose, Camellia Sinensis (Green Tea) Leaf Extract, Hamamelis Virginiana (Witch Hazel) Extract, Aloe Barbadensis Leaf Juice,  Camphor, Sodium Benzoate, Hydrolyzed Collagen

lab

ELF ZIT ERASER 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-017
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)
ALCOHOL (UNII: 3K9958V90M)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
CAMPHOR OIL (UNII: 75IZZ8Y727)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-017-01	4 g in 1 TUBE; Type 0: Not a Combination Product	01/29/2012	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/29/2012	12/31/2017

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

Revised: 3/2012

Document Id: 161de8ff-5fc8-49b6-9ef5-efa2763a0397

34390-5

Set id: bb9532e2-a424-40fc-9155-d5f92840f410

Version: 3

Effective Time: 20120329