FDA.reportPublic FDA data

salicylic gel

Manufacturer
Malin and Goetz Inc
Effective date
2022-11-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:52:01

Label at a glance#

Productsalicylic gel
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Salicylic Acid 2%--------Acne Treatment

OTC - PURPOSE SECTION

Uses

For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

Warnings:

For external use only.

When using this product

Avoid contact with eyes. If contact occurs, immediately flush with water.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase totwo oe three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water/Aqua/Eau, Alcohol Denat., Glycerin, Lactic Acid, Hydroxyethylcellulose, Sodium Hydroxide, Centella Asiatica Extract, Niacinamide, Phenoxyethanol, Salix Alba (Willow) Bark Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Disodium EDTA, Xanthan Gum, Mentha Piperita (Peppermint) Oil, Artemisia Absinthum Oil, Mentha Viridis (Spearmint) Leaf Oil, Tagetes Minuta Flower Oil, Achillea Millefolium Flower Extract.

OTHER SAFETY INFORMATION

Other Information

Protect the product in this container from excessive heat and direct sun.

INDICATIONS & USAGE SECTION

Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

(MALIN+GOETZ)

salicylic gel.

2% Salicylic Acid. Acne Gel

Daytime Treatment

0.5fl.oz./15ml

Salicylic Gel cartonSalicylic Gel carton

salicylic gel tubesalicylic gel tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
346298salicylic acid 2 % Topical GelPSN1
346298salicylic acid 0.02 MG/MG Topical GelSCD1
346298salicylic acid 2 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53634-153-012024-01-30C16284748780-11030e365-6797-111a-e063-dadaa90a10e2salicylic gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53634-153-01salicylic gel15 mL in 1 TUBEGEL151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53634-153SALICYLIC GEL (SALICYLIC ACID) GEL [MALIN AND GOETZ INC]1Legacy NDC, 1 package rows20221202_ee2acdf0-e5dc-9691-e053-2995a90ab49e.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53634-15353634-153-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALIX ALBA BARK205MXS71H7IACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
XANTHAN GUMTTV12P4NEEIACT
PEPPERMINT OILAV092KU4JHIACT
TAGETES MINUTA FLOWER OIL1T0ZMU8M8BIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
LACTIC ACID33X04XA5ATIACT
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
SODIUM HYDROXIDE55X04QC32IIACT
NIACINAMIDE25X51I8RD4IACT
WORMWOOD OIL01756N87N8IACT
SPEARMINT OILC3M81465G5IACT
ACHILLEA MILLEFOLIUM FLOWERYQR8R0SQEAIACT

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
ee2acdf0-e5dd-9691-e053-2995a90ab49eee2acdf0-e5dc-9691-e053-2995a90ab49e2022-11-23WarningsExact identifier
spl id: ee2acdf0-e5dd-9691-e053-2995a90ab49e
spl set id: ee2acdf0-e5dc-9691-e053-2995a90ab49e

Reported adverse events (FAERS/openFDA)#

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