FDA.reportPublic FDA data

Salicylic Acid

Manufacturer
Alps South, LLC | Alps South LLC
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:41:09

Label at a glance#

ProductSalicylic Acid
Active ingredientSALICYLIC ACID
Label structure10 sections

Dosage and administration

Lotion Topical

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid .5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only.

Do not apply over open wounds or infection.

Avoid contact with eyes. If contact occurs, rinse

thoroughly with water.

OTC - WHEN USING SECTION

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Lotion
  • Topical

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Avocado Butter, Mineral Oil, Petrolatrum, Glycerin, Pentaerythritol Tetrakis, Stearic Acid, Vitamin E Oil, Steareth 2, Steareth 21, Sorbitan Stearate, Sorbitan Oleate, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 80, Cetyl Alcohol, Polysorbate 20, Fragrance

INSTRUCTIONS FOR USE SECTION

  • Clean the skin thoroughly before applying cream.
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excesive drying of the skin may occur, start with one application daily. Gradually increase to two or three times daily if needed or as directed by a doctor.
  • If botherome dryness or peeling occurs, reduce application to once a day or every other day.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acne Cream LabelAcne Cream Label

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67146-012967146-0129-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
STEARETH-2V56DFE46J5IACT
POLYSORBATE 806OZP39ZG8HIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
HYDROGENATED AVOCADO OILJA69U4B4XIIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
CETYL ALCOHOL936JST6JCNIACT
STEARETH-2153J3F32P58IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYSORBATE 207T1F30V5YHIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
ff97c871-ae31-2c2a-e053-6394a90aecbab371db83-f557-fb64-e053-2a95a90aa5362023-07-03WarningsExact identifier
spl set id: b371db83-f557-fb64-e053-2a95a90aa536

Reported adverse events (FAERS/openFDA)#

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