FDA.reportPublic FDA data

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

Manufacturer
Home Smart Products | Jell Pharmaceuticals Pvt. Ltd.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:47:53

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

alcohol-50alcohol-50

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616456isopropyl alcohol 50 % Topical SolutionPSN3
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD3
616456isopropyl alcohol 50 % Topical SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52862-023-03ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN119 mL in 1 BOTTLE, PLASTICLIQUID1193
52862-023-04ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN178 mL in 1 BOTTLE, PLASTICLIQUID1783
52862-023-06ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN237 mL in 1 BOTTLE, PLASTICLIQUID2373
52862-023-09ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN295 mL in 1 BOTTLE, PLASTICLIQUID2953
52862-023-10ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN354 mL in 1 BOTTLE, PLASTICLIQUID3543
52862-023-11ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN414 mL in 1 BOTTLE, PLASTICLIQUID4143
52862-023-12ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN473 mL in 1 BOTTLE, PLASTICLIQUID4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52862-023ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [HOME SMART PRODUCTS]3Current NDC, Legacy NDC, 7 package rows20241222_ce735a5f-0502-44ca-b2d6-db97ad0c01cb.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
52862-02352862-023-03, 52862-023-04, 52862-023-06, 52862-023-09, 52862-023-10, 52862-023-11, 52862-023-12

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 ALCOHOLHome Smart Productsce735a5f-0502-44ca-b2d6-db97ad0c01cb2024-12-19WarningsExact identifier
ndc (package): 52862-023-09
ndc (package): 52862-023-11
ndc (package): 52862-023-06
ndc (package): 52862-023-10
ndc (package): 52862-023-04
ndc (package): 52862-023-03
ndc (package): 52862-023-12
ndc (product): 52862-023
ndc11 (package): 52862002312
ndc11 (package): 52862002306
ndc11 (package): 52862002311
ndc11 (package): 52862002303
ndc11 (package): 52862002310
ndc11 (package): 52862002309
ndc11 (package): 52862002304
spl id: 29a2950e-791c-ae41-e063-6294a90a3fd2
spl set id: ce735a5f-0502-44ca-b2d6-db97ad0c01cb

Reported adverse events (FAERS/openFDA)#

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