ELF ZIT ZAPPING CONCELER - salicylic acid paste 
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 sun.

Inactive Ingredient:

Octyl Palmitate, Caprylic/Capric Triglyceride, Octyl Dodecanol, Mica, Microstalline Wax, Cinnamomum Camphora (Camphor) Bark oil, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Phenoxyethanol, Ethylhexylglycerin

May Contain:

Iron Oxide (CI77491, CI77492, CI77499), Titanium Dioxide

lablabel

ELF ZIT ZAPPING CONCELER 
salicylic acid paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76354-018
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
MICROCRYSTALLINE WAX 
TEA TREE OIL 
ETHYLHEXYL PALMITATE 
CAMPHOR OIL 
ETHYLHEXYLGLYCERIN 
MICA 
PHENOXYETHANOL 
MEDIUM-CHAIN TRIGLYCERIDES 
OCTYLDODECANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76354-018-011.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/02/2012
Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai J. A. Cosmetics Trading CO., LTD.421280183manufacture

Revised: 3/2012
 
J. A. Cosmetics U.S. INC