FDA.reportPublic FDA data

Sebaceous Hyperplasia Treatment

Manufacturer
The Skin Atelier, Inc.
Effective date
2013-03-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:09:49

Label at a glance#

ProductSebaceous Hyperplasia Treatment
Active ingredientSALICYLIC ACID
Label structure7 sections

Label contents#

Full prescribing information#

INSTRUCTIONS FOR USE SECTION

Apply to affected area once a day immediately after cleansing.

DOSAGE & ADMINISTRATION SECTION

Apply to affected area once a day immediately after cleansing.

WARNINGS SECTION

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.

WARNINGS AND PRECAUTIONS SECTION

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.

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

Treats sebaceous hyperplasia.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SebaceuousHyperplasiaGelFinal.jpgSebaceuousHyperplasiaGelFinal.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71393-01371393-013-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALCOHOL3K9958V90MIACT
GLYCOLIC ACID0WT12SX38SIACT
TROLAMINE9O3K93S3TKIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5f10cc6b-8bc0-0b20-e053-2991aa0ac19d5f10cc6b-8bbf-0b20-e053-2991aa0ac19d2013-03-27WarningsExact identifier
spl id: 5f10cc6b-8bc0-0b20-e053-2991aa0ac19d
spl set id: 5f10cc6b-8bbf-0b20-e053-2991aa0ac19d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.