ELF Clarifying Pressed by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD. Drug Fact

ELF Clarifying Pressed by

Drug Labeling and Warnings

ELF Clarifying Pressed 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 CLARIFYING PRESSED - salicylic acid powder 
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:

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:

Talc, Mica, Kaolin, Paraffinium Liquidum (Mineral Oil), Titanium Dioxide, Cyclomethicone, Zinc Stearate, Petrolatum, Methylparaben, Propylparaben, Fragrance

May Contain:

Iron Oxide (CI77491, CI77492, CI77499), Red Np. 27 Lake (CI 45410), Red No. 7 Lake (CI 15850), Yellow No. 5 Lake (CI 19140), Blue No. 1 Lake (CI 42090), Ultramannes (CI 77007)

lablabel

ELF CLARIFYING PRESSED 
salicylic acid powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76354-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
MICA (UNII: V8A1AW0880)  
KAOLIN (UNII: 24H4NWX5CO)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
ZINC STEARATE (UNII: H92E6QA4FV)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
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: 76354-001-015 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/201112/05/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/01/201112/05/2019
Labeler - J. A. Cosmetics U.S. INC (186705047)

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