Sebaceous Hyperplasia Treatment

SEBACEOUS HYPERPLASIA TREATMENT- salicylic acid 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.

Apply to affected area once a day immediately after cleansing.

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.

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.

http://medlibrary.org/lib/images-rx/sebaceous-hyperplasia-treatment/sebaceuoushyperplasiagelfinal.jpg

SEBACEOUS HYPERPLASIA TREATMENT
sebaceous hyperplasia treatment gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71393-013
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 8 g in 100 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
PROPYLENE GLYCOL
FD&C BLUE NO. 1
ALCOHOL
GLYCOLIC ACID
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71393-013-04 4 g in 1 TUBE, WITH APPLICATOR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/27/2013
Labeler — The Skin Atelier, Inc. (135049810)
Establishment
Name Address ID/FEI Operations
The Skin Atelier, Inc. 135049810 manufacture (71393-013)

Revised: 03/2013 The Skin Atelier, Inc.

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