ELF Conceler Pencil and Brush by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD. Drug Fact

ELF Conceler Pencil and Brush by

Drug Labeling and Warnings

ELF Conceler Pencil and Brush 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 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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Drug Fact

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V) 15 g  in 100 g
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
CANDELILLA WAX (UNII: WL0328HX19)  
TEA TREE OIL (UNII: VIF565UC2G)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
MINERAL OIL (UNII: T5L8T28FGP)  
CAMPHOR OIL (UNII: 75IZZ8Y727)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PETROLATUM (UNII: 4T6H12BN9U)  
MICA (UNII: V8A1AW0880)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76354-004-012.93 g in 1 TUBE; Type 0: Not a Combination Product10/01/201112/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/01/201112/31/2017
Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 4/2012
 
J. A. Cosmetics U.S. INC