FDA.reportPublic FDA data

Gly-Sal 10-2 Pads

Manufacturer
Topiderm, Inc. | Topix Pharmaceuticals, Inc.
Effective date
2019-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:24

Label at a glance#

ProductGly-Sal 10-2 Pads
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

Cleansing pads for the treatment of acne, with the skin enhancement properties of Glycolic acid.

Dosage and administration

Wipe the entire affected area with a moist pad one to three times daily. Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid USP, 2%

Purpose

OTC - PURPOSE SECTION

Acne medication

Uses

INDICATIONS & USAGE SECTION

Cleansing pads for the treatment of acne, with the skin enhancement properties of Glycolic acid.

Warnings

WARNINGS SECTION

  • For external use only.
  • Keep away from eyes, lips, and mouth.

OTC - STOP USE SECTION

  • If irritation develops, discontinue use and consult a doctor.

SPL UNCLASSIFIED SECTION

  • Using other topical acne medication 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.

SPL UNCLASSIFIED SECTION

  • Flammable; keep tightly closed, away from flame and heat.
  • Sunscreen use is recommended with any Glycolic Acid product and for an additional week thereafter, because some individuals may be more sensitive to sunlight.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wipe the entire affected area with a moist pad one to three times daily.
  • Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Glycolic Acid, SD Alcohol 40B(13% v/v), Hamamelis Virginiana (Witch Hazel) Water, Ammonium Hydroxide, Polysorbate-20, Sodium Benzoate, Imidazolidinyl Urea, Acetone, Disodium EDTA.

PRINCIPAL DISPLAY PANEL - 60 Pad Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REPLENiX®
ACNE SOLUTIONS

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

Gly/Sal® 10-2
Pads

Glycolic Acid 10%
Salicylic Acid USP, 2%

60 Pads

PRINCIPAL DISPLAY PANEL - 60 Pad Jar Label
PRINCIPAL DISPLAY PANEL - 60 Pad Jar Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797892salicylic acid 2 % Medicated PadPSN4
797892salicylic acid 20 MG/ML Medicated PadSCD4
797892salicylic acid 2 % Medicated PadSY4
797892salicylic acid 2 % Topical SwabSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-039-60Gly-Sal 10-2 Pads60 in 1 JARCLOTH604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-039GLY-SAL 10-2 PADS (SALICYLIC ACID) CLOTH [TOPIDERM, INC.]4Current NDC, Legacy NDC, 1 package rows20231108_b39e845d-4c40-4f9e-9cb5-a8386f326652.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-03951326-039-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
GLYCOLIC ACID0WT12SX38SIACT
ALCOHOL3K9958V90MIACT
HAMAMELIS VIRGINIANA TOP WATERNT00Y05A2VIACT
AMMONIA5138Q19F1XIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM BENZOATEOJ245FE5EUIACT
IMIDUREAM629807ATLIACT
ACETONE1364PS73AFIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT

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
Gly-Sal 10-2 PadsSALICYLIC ACIDTopiderm, Inc.b39e845d-4c40-4f9e-9cb5-a8386f3266522019-10-23WarningsExact identifier
ndc (package): 51326-039-60
ndc (product): 51326-039
ndc11 (package): 51326003960
spl id: 39700b88-6308-4682-b1b2-107140d92913
spl set id: b39e845d-4c40-4f9e-9cb5-a8386f326652

Reported adverse events (FAERS/openFDA)#

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