FDA.reportPublic FDA data

50 Wintergreen Alcohol

Manufacturer
Iron Lab SA de CV
Effective date
2026-02-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:46:02

Label at a glance#

Product50 Wintergreen Alcohol
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Thoroughly cover your hands with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

INDICATIONS & USAGE SECTION

Thoroughly cover your hands with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

INACTIVE INGREDIENT SECTION

purified water, methyl salicylate, FD&C Blue #1, FD&C Yelloww #5

OTHER SAFETY INFORMATION

Store below 105°F. May discolor some fabrics. Harmful to wood finishes and plastic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - ASK DOCTOR SECTION

Irritation or redness develops. Condition persist for more than 72 hours.

WARNINGS SECTION

For external use only: hands. Flammable, Keep away from fire of flame.

OTC - ACTIVE INGREDIENT SECTION

50% Ethyl Alcohol

OTC - PURPOSE SECTION

Antiseptic Alcohol

OTC - DO NOT USE SECTION

Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WinterGreen 50WinterGreen 50WinterGreen 50

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2710538ethanol 50 % Topical SolutionPSN2
2710538ethanol 0.5 ML/ML Topical SolutionSCD2
2710538ethanol 50 % Topical SolutionSY2
2710538ethyl alcohol 50 % Topical SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74375-040-0150 Wintergreen Alcohol355 mL in 1 BOTTLE, PUMPLIQUID3552

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74375-04074375-040-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
50 Wintergreen AlcoholALCOHOLIron Lab SA de CV323baeb1-e3ee-ec70-e063-6294a90a30f02026-02-17WarningsExact identifier
ndc (package): 74375-040-01
ndc (product): 74375-040
ndc11 (package): 74375004001
spl id: 4b08c5df-1e8f-f2a1-e063-6394a90aca11
spl set id: 323baeb1-e3ee-ec70-e063-6294a90a30f0

Reported adverse events (FAERS/openFDA)#

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