FDA.reportPublic FDA data

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

Manufacturer
Universal Distribution Center LLC | Jell Pharmaceuticals Pvt. Ltd.
Effective date
2025-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:43

Label at a glance#

ProductISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (by volume)

Isopropyl alcohol (50% concentrate)

OTC - PURPOSE SECTION

Purpose

topical antimicrobial

INDICATIONS & USAGE SECTION

Uses

  • to decrease germs in minor cuts and scrapes
  • helps relieve minor muscular aches due to exertion

WARNINGS SECTION

Warnings

For external use only

  • flammable, keep away from fire and flame
  • will produce serious gastric disturbances if taken internally

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you havedeep puncture wounds or serious burns

OTC - DO NOT USE SECTION

When using this product

  • do not get into eyes or mucous membranes
  • use only in a well-ventilated area

OTC - STOP USE SECTION

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.

In case of an accidental ingestion, contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply to skin directly of with clean gauze, cotton or swab
  • for rubbing apply liberally and rub with hands

SPL UNCLASSIFIED SECTION

Other information

  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • keep bottle tightly closed

INACTIVE INGREDIENT SECTION

Inactive ingredient

Water, methyl salicylate, laneth-75, FD&C Blue #1, FD&C Yellow #5

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

HEALTH SMART ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

TOPICAL ANTIMICROBIAL

12 FL.OZ (354 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616456isopropyl alcohol 50 % Topical SolutionPSN1
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD1
616456isopropyl alcohol 50 % Topical SolutionSY1

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
52000-802-01ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN119 mL in 1 BOTTLE, PLASTICLIQUID1191
52000-802-02ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN178 mL in 1 BOTTLE, PLASTICLIQUID1781
52000-802-03ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN237 mL in 1 BOTTLE, PLASTICLIQUID2371
52000-802-04ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN295 mL in 1 BOTTLE, PLASTICLIQUID2951
52000-802-05ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN354 mL in 1 BOTTLE, PLASTICLIQUID3541
52000-802-06ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN414 mL in 1 BOTTLE, PLASTICLIQUID4141
52000-802-07ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN473 mL in 1 BOTTLE, PLASTICLIQUID4731
52000-802-08ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN946 mL in 1 BOTTLE, PLASTICLIQUID9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-802ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [UNIVERSAL DISTRIBUTION CENTER LLC]1Current NDC, 8 package rows20250308_2f9846ce-37ca-a95b-e063-6294a90ad260.zip

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
52000-80252000-802-01, 52000-802-02, 52000-802-03, 52000-802-04, 52000-802-05, 52000-802-06, 52000-802-07, 52000-802-08

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
METHYL SALICYLATELAV5U5022YIACT
PEG-75 LANOLIN09179OX7TBIACT
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 LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
ndc (package): 52000-802-08
ndc (package): 52000-802-07
ndc (package): 52000-802-05
ndc (package): 52000-802-03
ndc (package): 52000-802-06
ndc (package): 52000-802-04
ndc (package): 52000-802-01
ndc (package): 52000-802-02
ndc (product): 52000-802
ndc11 (package): 52000080204
ndc11 (package): 52000080201
ndc11 (package): 52000080208
ndc11 (package): 52000080207
ndc11 (package): 52000080206
ndc11 (package): 52000080205
ndc11 (package): 52000080203
ndc11 (package): 52000080202
spl id: 2f984580-5e4d-ace5-e063-6294a90a71a5
spl set id: 2f9846ce-37ca-a95b-e063-6294a90ad260

Reported adverse events (FAERS/openFDA)#

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