ELF Zit Zapping Conceler by J. A. Cosmetics U.S. INC

ELF Zit Zapping Conceler by

Drug Labeling and Warnings

ELF Zit Zapping Conceler by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELF ZIT ZAPPING CONCELER- 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 1.0%

PURPOSE

ACNE TREATMENT

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.
• Using other tropical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.  If this occurs, only one medication should be used unless directed by a doctor.

Stop use and ask a doctor if

• rash occurs

Keep Out of Reach of Children

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:

Protect the product in its container from excessive heat and direct sun.

Inactive Ingredient:

Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Octyldodecanol, Diisostearyl Malate, Methyl Methacrylate Crosspolymer, Mica, Polyglyceryl-4 Isostearate, Microcrystalline Wax (Cera Microcristallina), Camphor, Melaleuca Alternafolia (Tea Tree) Leaf Oil

May Contain:

Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499), Blue 1 Lake (CI 42090)

ELF ZIT ZAPPING CONCELER 
salicylic acid paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-018
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
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
METHYL METHACRYLATE (UNII: 196OC77688)
MICA (UNII: V8A1AW0880)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
TEA TREE OIL (UNII: VIF565UC2G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-018-51	1 in 1 PACKAGE	01/02/2012	12/31/2017
1	NDC: 76354-018-01	1.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/02/2012	12/31/2017

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

Revised: 6/2014

Document Id: 43375e2e-08af-462c-8ccf-82b9e365fe84

34390-5

Set id: e68bd1fb-51d2-409b-80ac-ae0cc75eb18c

Version: 4

Effective Time: 20140617

 

J. A. Cosmetics U.S. INC