ELF Zit Zapping Conceler

Dosage form: paste
Ingredients: SALICYLIC ACID 1.0g in 100g
Labeler: J. A. Cosmetics U.S. INC
NDC Code: 76354-018

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.

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.
  • Using other tropical 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 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:

Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Octyldodecanol, Diisostearyl Malate, Methyl Methacrylate Crosspolymer, Mica, Polyglyceryl-4 Isostearate, Microcrystalline Wax (Cera Microcristallina), Camphor, Melaleuca Alternafolia (Tea Tree) Leaf Oil

May Contain:

Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499), Blue 1 Lake (CI 42090)

ELF ZIT ZAPPING CONCELER 
salicylic acid paste
Product Information
Product TypeHUMAN OTC DRUGItem 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
MEDIUM-CHAIN TRIGLYCERIDES 
ETHYLHEXYL PALMITATE 
OCTYLDODECANOL 
DIISOSTEARYL MALATE 
METHYL METHACRYLATE 
MICA 
POLYGLYCERYL-4 ISOSTEARATE 
MICROCRYSTALLINE WAX 
CAMPHOR (SYNTHETIC) 
TEA TREE OIL 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:76354-018-511 TUBE in 1 PACKAGE
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)

Revised: 06/2014
 
J. A. Cosmetics U.S. INC

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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