FDA.reportPublic FDA data

Salicylic Acid

Manufacturer
CVS Pharmacy, Inc
Effective date
2016-02-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:10

Label at a glance#

ProductSalicylic Acid
Active ingredientSALICYLIC ACID
Label structure10 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 rom 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 barbadesis leaft extract, benzophenone-4, denatonium benzoate, dimethicone propyl PG-betaine, fragrance, glycerin, isoceteth-20, PEG-32, propylene glycol, sodium citrate, water, blue 1

SPL UNCLASSIFIED SECTION

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

(c) 2015 CVS/pharmacy

CVS.com 1-800-SHOP CVS

Made in the USA with US and foreign components

DSP-TN-15000 DSP-MO-34  SDS-TN-15012

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Clean & Clear Sensitive Skin Deep Cleaning Toner*

CVS Health

Deep Cleaning Toner

salicylic acid acne medication

  • gentle formula that treats and prevent pimples
  • cleans & refreshes by removing dirt & oil

Sensitive skin

8 FL OZ (237 mL)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199308salicylic acid 0.5 % Topical SolutionPSN1
199308salicylic acid 5 MG/ML Topical SolutionSCD1
199308salicylic acid 0.5 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-961-342020-01-31C16284748780-19d75b9d0-e2b1-f424-e053-dadaa90a57ceDrug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-961-34Salicylic Acid237 mL in 1 BOTTLE, PLASTICLIQUID2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-961SALICYLIC ACID (ASTRINGENT) LIQUID [CVS PHARMACY, INC]1Current NDC, Legacy NDC, 1 package rows20160225_be5e8816-9dcd-41ff-aa53-15ce027a91f3.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-96159779-961-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
ALCOHOL3K9958V90MIACT
LAMINARIA DIGITATA15E7C67EE8IACT
ALOEV5VD430YW9IACT
BENZOPHENONE701M4TTV9OIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
ISOCETETH-20O020065R7ZIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
SODIUM CITRATE1Q73Q2JULRIACT
water059QF0KO0RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oil Free Acne WashSALICYLIC ACID 2%CVS Pharmacy, Inc.7a8225ab-b60a-4978-bdfe-db0b00307ef12026-02-03WarningsExact identifier
ndc (product): 59779-961
75210937-9de9-45a0-81e7-2690804356ecbe5e8816-9dcd-41ff-aa53-15ce027a91f32016-02-15WarningsExact identifier
spl id: 75210937-9de9-45a0-81e7-2690804356ec
spl set id: be5e8816-9dcd-41ff-aa53-15ce027a91f3

Reported adverse events (FAERS/openFDA)#

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