ELF CONCELER PENCIL AND BRUSH  - 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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Active Ingredient:

Salicylic Acid 2.0%

Purpose:

Anti-Acne

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.

Tell Your Doctor And Pharmacist If

You are allergic to salicylic acid or any other medications

Keep Out of Reach of Children:

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

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:

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

Inactive Ingredient:

Synthetic Beeswax, Microstalline Wax, Euphorbia Cerifera (Candelilla) Wax, Hydrogenated Castor Oil, Ethylhexy Palmitate, Paraffinium Liquidum (Mineral Oil), Bis-Diglyceryl Polyacyladipate-2, Isopropyl Myristate, Petrolatum, Mica, Melaleuca Alternafolia (Tea Tree) Leaf Oil, BHT, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone.

May Contain:

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

lablabel


ELF CONCELER PENCIL AND BRUSH 
salicylic acid paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX15 g  in 100 g
MICROCRYSTALLINE WAX 
CANDELILLA WAX 
TEA TREE OIL 
ETHYLHEXYL PALMITATE 
MINERAL OIL 
CAMPHOR OIL 
ISOPROPYL MYRISTATE 
PETROLATUM 
MICA 
BUTYLATED HYDROXYTOLUENE 
BENZYL ALCOHOL 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:76354-004-012.93 g in 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/01/2011

Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIOperations
Shanghai Justking Enterprise Co. Ltd.421267459manufacture

Revised: 10/2011 J. A. Cosmetics U.S. INC