FDA.reportPublic FDA data

Salicylic Acid

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:44:19

Label at a glance#

ProductSalicylic Acid
Active ingredientSALICYLIC ACID
Label structure11 sections

Dosage and administration

clean the skin thoroughly before applying this product cover the entire affected area with a thin layer and rinse thoroughly one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce daily application to once a day or every other day

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 0.5%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Flammable. Keep away from fire or flame.

When using this product

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

Keep out of reach of children.

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

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce daily application to once a day or every other day

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol (24.5%), algae extract, aloe barbadensis leaf extract, benzophenone-4, denatonium benzoate, dimethicone propyl PG-betaine, fragrance, glycerin, isoceteth-20, PEG-32, propylene glycol, sodium citrate, water, blue 1

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

ADVERSE REACTION

ADVERSE REACTIONS SECTION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Clean & Clear ®Sensitive Skin Deep Cleaning Astringent.

Visit us here for more information: topbrands.com

DISTRIBUTED BY TOPCO ASSOCIATES LLC

150 NORTHEST POINT BOULEVARD

ELK GROVE VILLAGE, IL 60007

1-888-423-0139 TOPCO VIJA0119

topcare@ topco.com

QUALITY GUARANTEED

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare

beauty™

DEEP CLEANING

ASTRINGENT

Salicylic Acid

Acne Medication

Compare to CLEAN & CLEAR ®*

Gentle formula that treats & helps prevent pimples

Sensitive Skin

8 FL OZ (237 mL)

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199308salicylic acid 0.5 % Topical SolutionPSN13
199308salicylic acid 5 MG/ML Topical SolutionSCD13
199308salicylic acid 0.5 % Topical SolutionSY13

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800093263GTIN-13: 0036800093263
EAN-13: 0036800093263
GTIN-12: 036800093263
UPC-A: 036800093263
GTIN storage (14 digits): 00036800093263		mm02.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-875-34Salicylic Acid237 mL in 1 BOTTLE, PLASTICLIQUID23713

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-87536800-875-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ALOEV5VD430YW9IACT
BENZOPHENONE701M4TTV9OIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
ISOCETETH-20O020065R7ZIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML · Source PDF

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
Salicylic AcidASTRINGENTTopco Associates LLC7d15560f-d8d1-4dfe-8eca-b16bb529ad872026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 36800-875-34
ndc (product): 36800-875
ndc11 (package): 36800087534
spl id: 4ab9e538-f943-9d4c-e063-6394a90a30ce
spl set id: 7d15560f-d8d1-4dfe-8eca-b16bb529ad87

Reported adverse events (FAERS/openFDA)#

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