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ELF Zit Zapper by J. A. Cosmetics U.S. INC

Dosage form: liquid
Ingredients: SALICYLIC ACID 1.0g in 100g
Labeler: J. A. Cosmetics U.S. INC
NDC Code: 76354-003

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID1.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER86.70 g  in 100 g
HAMAMELIS VIRGINIANA LEAF 
ALCOHOL 
TEA TREE OIL 
C13-14 ISOPARAFFIN 
LAURETH-7 
CAMPHOR OIL 
Packaging
#Item CodePackage Description
1NDC:76354-003-016 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/09/2011
Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIOperations
Shanghai J. A. Cosmetics Trading CO., LTD.421280183manufacture

Revised: 04/2012
 
J. A. Cosmetics U.S. INC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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