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Isopropyl alcohol

Drug Facts

Approved
Approval ID

1a3a789d-8c51-4661-84fe-df80ed70e6f1

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

Family Dollar (FAMILY WELLNESS)

DUNS: 024472631

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Isopropyl alcohol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55319-570
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Isopropyl alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (2)

ISOPROPYL ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: ND2M416302
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/23/2025

Package Label

![Family Wellness Isopropyl Alcohol 70% front image](/dailymed/image.cfm?name=isopropyl-alcohol-70-percent- liquid-1.jpg&id=899056)

Isopropyl Alcohol 70% front image

![Family Wellness Isopropyl Alcohol 70% back image](/dailymed/image.cfm?name=isopropyl-alcohol-70-percent- liquid-2.jpg&id=899056)

Isopropyl Alcohol 70% back image

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/23/2025

Uses

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/23/2025

Active ingredient (by volume)

Isopropyl alcohol (70% conc.)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/23/2025

Purpose

First aid antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 9/23/2025

Warnings

For external use only.

  • if taken internally, serious gastic disturbances will result

flammable, keep away from fire or flame.

*use only in a well-ventilated area; fumes may be toxic

Ask a doctor before use if you have

deep or puncture woods, 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 one week unless directed by a doctor

Stop use and ask a doctor if

condition persists or gets worse.

Keep out of reach of children.

In case of ingestion, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/23/2025

Directions

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/23/2025

Other information

  • store at room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/23/2025

Inactive ingredient

purified water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/23/2025

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Isopropyl alcohol - FDA Drug Approval Details