FDA.reportPublic FDA data

Gly-Sal 10-2 Spray

Manufacturer
Topiderm, Inc.
Effective date
2024-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:38

Label at a glance#

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

Indications and uses

For the treatment of acne of the body, with the skin enhancement properties of glycolic acid

Dosage and administration

Spray the entire affected area of the body 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 2%

Purpose

OTC - PURPOSE SECTION

Acne medication

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne of the body, with the skin enhancement properties of glycolic acid

Warnings

WARNINGS SECTION

  • For external use only.
  • Direct spray away from face, especially eyes, lips and mouth.
  • If irritation develops, discontinue use and consult a doctor.
  • 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.
  • 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

  • Spray the entire affected area of the body 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

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

PRINCIPAL DISPLAY PANEL - 89 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPLIMENTS OF

TOPIX
PHARMACEUTICALS, INC

Gly/Sal 10-2
Spray

Glycolic Acid 10%
Salicylic Acid USP, 2%

Net 3 fl. oz. (89 ml)

Available
Custom Branded
800.445.2595
c.service@topixpharm.com

PRINCIPAL DISPLAY PANEL - 89 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 89 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1048903salicylic acid 2 % Topical SprayPSN1
1048903salicylic acid 20 MG/ML Topical SpraySCD1
1048903salicylic acid 2 % Topical SpraySY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-938-01Gly-Sal 10-289 mL in 1 BOTTLE, PLASTICLIQUID891

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-938GLY-SAL 10-2 (SALICYLIC ACID) LIQUID [TOPIDERM, INC.]1Current NDC, 1 package rows20240615_661cc58b-9360-4b96-b405-afdc2e378397.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-93851326-938-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
GLYCOLIC ACID0WT12SX38SIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
EDETATE DISODIUM7FLD91C86KIACT
LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE5Q87K461JOIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
SODIUM C12-15 ALKETH-15 SULFONATE353VA59XH8IACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
TROLAMINE9O3K93S3TKIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ZINC PIDOLATEC32PQ86DH4IACT

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 10-2SALICYLIC ACIDTopiderm, Inc.661cc58b-9360-4b96-b405-afdc2e3783972024-06-13WarningsExact identifier
ndc (package): 51326-938-01
ndc (product): 51326-938
ndc11 (package): 51326093801
spl id: fa80848d-48a6-42b9-862d-e6094b41cee6
spl set id: 661cc58b-9360-4b96-b405-afdc2e378397

Reported adverse events (FAERS/openFDA)#

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