FDA.reportPublic FDA data

Isopropyl Rubbing Alcohol 50% with Wintergreen

Manufacturer
Universal Distribution Center LLC
Effective date
2024-10-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:47

Label at a glance#

ProductIsopropyl Rubbing Alcohol 50% with Wintergreen
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (by volume)

Isopropyl alcohol (50% conc.)

OTC - PURPOSE SECTION

Purpose

First aid antiseptic

INDICATIONS & USAGE SECTION

Uses

  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns

WARNINGS SECTION

Warnings

For external use only; flammable, keep away from fire or flame, heat, spark, electrical

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • deep punctured wounds, animal bites or serious burns

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop using this product if

  • condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1212) immediately

DOSAGE & ADMINISTRATION SECTION

Directions

  • clean effected area
  • apply small amount of this product on the area 1-3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

SPL UNCLASSIFIED SECTION

Other information

  • store at room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • will produce serious gastric disturbances if taken internally

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water(Aqua), Methyl Salicylate, FD&C Blue #1, FD&C Yellow #5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN
FIRST AID ANTISEPTIC
12 FL.OZ (355 mL)

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616456isopropyl alcohol 50 % Topical SolutionPSN2
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD2
616456isopropyl alcohol 50 % Topical SolutionSY2

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
52000-051-01Isopropyl Rubbing Alcohol 50% with Wintergreen118 mL in 1 BOTTLE, PLASTICLIQUID1182
52000-051-02Isopropyl Rubbing Alcohol 50% with Wintergreen177 mL in 1 BOTTLE, PLASTICLIQUID1772
52000-051-03Isopropyl Rubbing Alcohol 50% with Wintergreen237 mL in 1 BOTTLE, PLASTICLIQUID2372
52000-051-04Isopropyl Rubbing Alcohol 50% with Wintergreen296 mL in 1 BOTTLE, PLASTICLIQUID2962
52000-051-05Isopropyl Rubbing Alcohol 50% with Wintergreen355 mL in 1 BOTTLE, PLASTICLIQUID3552
52000-051-06Isopropyl Rubbing Alcohol 50% with Wintergreen414 mL in 1 BOTTLE, PLASTICLIQUID4142
52000-051-07Isopropyl Rubbing Alcohol 50% with Wintergreen473 mL in 1 BOTTLE, PLASTICLIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-051ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 7 package rows20241212_0b185535-b1af-4128-89ca-65b0e63cd430.zip

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
52000-05152000-051-01, 52000-051-02, 52000-051-03, 52000-051-04, 52000-051-05, 52000-051-06, 52000-051-07

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
WATER059QF0KO0RIACT
METHYL SALICYLATELAV5U5022YIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
Isopropyl Rubbing Alcohol 50% with WintergreenISOPROPYL ALCOHOLUniversal Distribution Center LLC0b185535-b1af-4128-89ca-65b0e63cd4302024-10-21WarningsExact identifier
ndc (package): 52000-051-07
ndc (package): 52000-051-02
ndc (package): 52000-051-04
ndc (package): 52000-051-03
ndc (package): 52000-051-06
ndc (package): 52000-051-01
ndc (package): 52000-051-05
ndc (product): 52000-051
ndc11 (package): 52000005101
ndc11 (package): 52000005102
ndc11 (package): 52000005104
ndc11 (package): 52000005107
ndc11 (package): 52000005103
ndc11 (package): 52000005106
ndc11 (package): 52000005105
spl id: 9230b2b6-11d4-4a90-a94d-dc67a992cadd
spl set id: 0b185535-b1af-4128-89ca-65b0e63cd430

Reported adverse events (FAERS/openFDA)#

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