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

lab

ELF CONCELER PENCIL AND BRUSH 
salicylic acid paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-004-01	2.93 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2011	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	10/01/2011	12/31/2017

Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 4/2012

Document Id: 10a9f4b2-4abc-4ffc-bec7-5592f007a85c

34390-5

Set id: 9a2ee3ce-3a6a-47ef-834a-83b174ed5cd5

Version: 3

Effective Time: 20120418

 

J. A. Cosmetics U.S. INC