FDA.reportPublic FDA data

Alcohol

Manufacturer
HART Health
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:32:39

Label at a glance#

ProductAlcohol
Active ingredientISOPROPYL ALCOHOL
Label structure10 sections

Indications and uses

First aid topical antiseptic to help prevent infection in: minor cuts scrapes burns abrasions

Dosage and administration

Adults and children 12 years of age and over apply topically to clean affected area 1 to 3 times daily when dry, may be covered with a sterile bandage if gets in eyes, flush thoroughly with water Children under 12 years of age ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Topical Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid topical antiseptic to help prevent infection in:

  • minor cuts
  • scrapes
  • burns
  • abrasions

Warnings

WARNINGS SECTION

For external use only

FLAMMABLE keep away from heat and flame

Do not use

OTC - DO NOT USE SECTION

  • with electrocautery procedures
  • in the eyes or apply over large portions of the body
  • on serious burns
  • on animal bites
  • on deep or puncture wounds

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms last more than 72 hours
  • redness, swelling, irritation or pain occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact  Poison Control Center right away 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over

  • apply topically to clean affected area 1 to 3 times daily
  • when dry, may be covered with a sterile bandage
  • if gets in eyes, flush thoroughly with water

Children under 12 years of age

  • ask a doctor

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2606 Alcohol 50ct bx v20f.jpg2606 Alcohol 50ct bx v20f.jpg2606 Alcohol 50ct bx v20f.jpg2606 Alcohol 50ct bx v20f.jpg2606 Alcohol 50ct bx v20f.jpg2606 Alcohol 50ct bx v20f.jpg2606 Alcohol 50ct bx v20f.jpg2606 Alcohol 50ct bx v20f.jpg2606 Alcohol 50ct bx v20f.jpg2606 Alcohol 50ct bx v20f.jpg2606 Alcohol 50ct bx v20f.jpg2606 Alcohol 50ct bx v20f.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN8
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD8
797544isopropyl alcohol 70 % Medicated PadSY8
797544isopropyl alcohol 70 % Topical ClothSY8
797544isopropyl alcohol 70 % Topical SwabSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50332-0046-02022-10-07C16284748780-1ba0f9c33-5348-a910-e053-dadaa90a0b85ALCOHOL WIPES
50332-0046-52022-10-07C16284748780-1ba0f9c33-5348-a910-e053-dadaa90a0b85ALCOHOL WIPES
50332-0046-72022-10-07C16284748780-1ba0f9c33-5348-a910-e053-dadaa90a0b85ALCOHOL WIPES
50332-0046-02021-01-29C16284748780-1ba0f9c33-5348-a910-e053-dadaa90a0b85ALCOHOL WIPES
50332-0046-52021-01-29C16284748780-1ba0f9c33-5348-a910-e053-dadaa90a0b85ALCOHOL WIPES
50332-0046-72021-01-29C16284748780-1ba0f9c33-5348-a910-e053-dadaa90a0b85ALCOHOL WIPES

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-004650332-0046-0, 50332-0046-5, 50332-0046-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT

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
AlcoholISOPROPYL ALCOHOLHART Health8d01b10b-7916-420e-9d44-ebd3806fe3152026-01-12WarningsExact identifier
ndc (package): 50332-0046-7
ndc (package): 50332-0046-0
ndc (package): 50332-0046-5
ndc (product): 50332-0046
ndc11 (package): 50332004605
ndc11 (package): 50332004607
ndc11 (package): 50332004600
spl id: d9c01925-067b-4f25-b324-ad35723a2afa
spl set id: 8d01b10b-7916-420e-9d44-ebd3806fe315

Reported adverse events (FAERS/openFDA)#

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