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)

lab

ELF CLARIFYING PRESSED 
salicylic acid powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-001-01	5 g in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2011	12/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	10/01/2011	12/05/2019

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

Revised: 4/2012

Document Id: 7f3b2c2d-1ac5-4c0e-bda1-f115801cd9fd

34390-5

Set id: f4785448-ac36-47e4-871c-c4b7e98a9311

Version: 3

Effective Time: 20120418

 

J. A. Cosmetics U.S. INC