FDA.reportPublic FDA data

Acne Spot Treatment

Manufacturer
Walgreens | Product Quest Mfg
Effective date
2018-02-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:39

Label at a glance#

ProductAcne Spot Treatment Walgreens
Active ingredientSalicylic Acid
Label structure6 sections

Indications and uses

For the treatment of acne

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                    Purpose

Salicylic Acid….2%                    Acne Treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne

WarningsFor external use onlyFlammable. Keep away from fire or flame.

WARNINGS SECTION

When using this product skin irritation and dryness is more likely occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

DOSAGE & ADMINISTRATION SECTION

Directions
Cleanse thoroughly before applying treatment
Cover the entire affected area with a thin layer one to three times daily.
Because of excessive drying of the skin may occurs, 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 application usage to once a day or every other day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Beeswax
Eucalyptus Globulus Leaf Oil
Fragrance
Myristica Fragrans (Nutmeg) Kernel Oil
Petrolatum
Ricinus Communis (Castor) Seed Oil
Thymol
Thuja Occidentalis Leaf Oil
Tocopheryl Acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251400salicylic acid 2 % Topical OintmentPSN2
251400salicylic acid 0.02 MG/MG Topical OintmentSCD2
251400salicylic acid 2 % Topical OintmentSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-1115-012020-01-31C16284748780-19d75b9d0-68a1-f424-e053-dadaa90a57ceFrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1115-01Acne Spot TreatmentWalgreens1 in 1 CARTONSTICK12
0363-1115-01Acne Spot TreatmentWalgreens20 g in 1 TUBESTICK202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1115ACNE SPOT TREATMENT WALGREENS (SALICYLIC ACID 2%) STICK [WALGREENS]2Legacy NDC, 2 package rows20180220_e575495a-9dd2-41bc-8d5a-82f6e9fbb376.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-11150363-1115-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
YELLOW WAX2ZA36H0S2VIACT
EUCALYPTUS OIL2R04ONI662IACT
NUTMEG OILZ1CLM48948IACT
Petrolatum4T6H12BN9UIACT
CASTOR OILD5340Y2I9GIACT
Thymol3J50XA376EIACT
CEDAR LEAF OILBJ169U4NLGIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
c7d2087c-ee79-41d7-93b6-ab6746492309e575495a-9dd2-41bc-8d5a-82f6e9fbb3762018-02-19WarningsExact identifier
spl id: c7d2087c-ee79-41d7-93b6-ab6746492309
spl set id: e575495a-9dd2-41bc-8d5a-82f6e9fbb376

Reported adverse events (FAERS/openFDA)#

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