FDA.reportPublic FDA data

Isopropyl Alcohol with Wintergreen 50%

Manufacturer
Hydrox Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:32:18

Label at a glance#

ProductIsopropyl Alcohol with Wintergreen 50%
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Isopropyl Alcohol 50%

OTC - PURPOSE SECTION

Purpose:

First Aid Antiseptic

INDICATIONS & USAGE SECTION

Usesfirst aid to help prevent the risk of infection in: minor cuts, scrapes, burns.

WARNINGS SECTION

Warnings For external use only

Flammable

  • Keep away from fire or flame, heat, spark, electrical. Flash point 72°F.
  • do not use with eletocautery procedures.

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

When using this product

  • do not get into eyes
  • do not apply over large areas of the body
  • do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions ●clean the affected area ● apply 1 to 3 times daily ● may be covered with a sterile bandage ● if bandaged, let dry first

WARNINGS AND PRECAUTIONS SECTION

Other information does not contain, nor is intended as a substitue for grain or ethyl alcohol. will produce serious gastric disturbances if taken internally.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

FD&C Blue No. 1, FD&C Yellow No. 5, Methyl Salicylate, PEG-75 Lanolin, Purified Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrox

Isopropyl Alcohol 50% with Wintergreen

A cooling and refreshing and massaging compound

First Aid Antiseptic

TAMPER EVIDENT CAP FOR YOUR PROTECTION. IF RING-BAND IS DETACHED FROM CAP OR MISSING, DO NOT USE.

WARNING: FLAMMABLE!

Hydrox Laboratories

Elgin, IL 60123

isopropylalcoholisopropylalcohol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616456isopropyl alcohol 50 % Topical SolutionPSN10
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD10
616456isopropyl alcohol 50 % Topical SolutionSY10

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130021599412630GTIN-13: 0021599412630
EAN-13: 0021599412630
GTIN-12: 021599412630
UPC-A: 021599412630
GTIN storage (14 digits): 00021599412630		Isopropylalcohol.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10565-007-04Isopropyl Alcohol with Wintergreen 50%118 mL in 1 BOTTLE, PLASTICSOLUTION11810
10565-007-08Isopropyl Alcohol with Wintergreen 50%237 mL in 1 BOTTLE, PLASTICSOLUTION23710
10565-007-16Isopropyl Alcohol with Wintergreen 50%473 mL in 1 BOTTLE, PLASTICSOLUTION47310
10565-007-32Isopropyl Alcohol with Wintergreen 50%946 mL in 1 BOTTLE, PLASTICSOLUTION94610
10565-007-99Isopropyl Alcohol with Wintergreen 50%3785 mL in 1 BOTTLE, PLASTICSOLUTION378510

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10565-00710565-007-04, 10565-007-08, 10565-007-16, 10565-007-32, 10565-007-99

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
METHYL SALICYLATELAV5U5022YIACT
PEG-75 LANOLIN09179OX7TBIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
Isopropyl Alcohol with Wintergreen 50%ISOPROPYL ALCOHOL WITH WINTERGREEN 50%Hydrox Laboratories3a15a900-2b48-487f-b252-a1a1e0d0abfc2026-01-12WarningsExact identifier
ndc (package): 10565-007-04
ndc (package): 10565-007-08
ndc (package): 10565-007-16
ndc (package): 10565-007-32
ndc (package): 10565-007-99
ndc (product): 10565-007
ndc11 (package): 10565000716
ndc11 (package): 10565000732
ndc11 (package): 10565000704
ndc11 (package): 10565000799
ndc11 (package): 10565000708
spl id: 48339b38-6f43-9dec-e063-6394a90a1bda
spl set id: 3a15a900-2b48-487f-b252-a1a1e0d0abfc

Reported adverse events (FAERS/openFDA)#

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