SEBACEOUS HYPERPLASIA TREATMENT- sebaceous hyperplasia treatment gel
The Skin Atelier, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Apply to affected area once a day immediately after cleansing.

Warning: For external use only. When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep out of reach of children. If swallowed get medical help or call Poison Control Center immediately.

Water, Ethanol, Glycerin, Propylene Glycol, Glycolic Acid, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Treats sebaceous hyperplasia.

SEBACEOUS HYPERPLASIA TREATMENT
sebaceous hyperplasia treatment gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:71393-013
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	8 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
GLYCOLIC ACID (UNII: 0WT12SX38S)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71393-013-04	4 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	03/27/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/27/2013	10/11/2019

Labeler - The Skin Atelier, Inc. (135049810)

Name	Address	ID/FEI	Business Operations
Establishment
The Skin Atelier, Inc.		135049810	manufacture(71393-013)

Revised: 1/2020

Document Id: 9c58b64f-fdd2-57ba-e053-2995a90a7901

Set id: 5f10cc6b-8bbf-0b20-e053-2991aa0ac19d

Version: 3

Effective Time: 20200117

The Skin Atelier, Inc.