Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 5ffa8ecf-1349-4758-8d47-e9a96d2ddaee
Route
TOPICAL
Published
Effective Date 2025-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (70 mL)
Inactive Ingredients
Fd&c Green No. 3 Fd&c Yellow No. 5 Methyl Salicylate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-20
Description

Isopropyl alcohol (70% conc.)

Purpose

First aid antiseptic

Medication Information

Purpose

First aid antiseptic

Description

Isopropyl alcohol (70% conc.)

Uses

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

Warnings

For external use only.

  • if taken internally, serious gastric disturbances will result

flammable, keep away from fire or flame

  • use only in a well-ventilated area; fumes may be toxic
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
Package Label
LEADER Isopropyl Alcohol 70% Wintergreen
Other Information
  • store at room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
Inactive Ingredients

FD&C green #3, FD&C yellow #5, methyl salicylate, purified water

Principal Display Panel

Isopropyl Alcohol 70%

Wintergreen with Methyl Salicylate

First Aid Antiseptic

For External Use Only

WARNING: FLAMMABLE | keep away from heat, spark, electrical, fire or flame

USE ONLY IN A WELL-VENTILATED AREA;

FUMES MAY BE TOXIC

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER THE CAP IS BROKEN OR MISSING.

DIST. BY CAH DUBLIN, OH 43017

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

Active Ingredient (by Volume)

Isopropyl alcohol (70% conc.)

Keep Out of Reach of Children.

In case of ingestion, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Before Use If You Have

deep or puncture woods, animal bites or serious burns

Structured Label Content

Uses

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

Purpose

First aid antiseptic

Warnings

For external use only.

  • if taken internally, serious gastric disturbances will result

flammable, keep away from fire or flame

  • use only in a well-ventilated area; fumes may be toxic
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
Package Label
LEADER Isopropyl Alcohol 70% Wintergreen
Other Information (Other information)
  • store at room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
Inactive Ingredients (Inactive ingredients)

FD&C green #3, FD&C yellow #5, methyl salicylate, purified water

Principal Display Panel

Isopropyl Alcohol 70%

Wintergreen with Methyl Salicylate

First Aid Antiseptic

For External Use Only

WARNING: FLAMMABLE | keep away from heat, spark, electrical, fire or flame

USE ONLY IN A WELL-VENTILATED AREA;

FUMES MAY BE TOXIC

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER THE CAP IS BROKEN OR MISSING.

DIST. BY CAH DUBLIN, OH 43017

When Using This Product (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 (Stop use and ask a doctor if)

condition persists or gets worse

Active Ingredient (by Volume) (Active ingredient (by volume))

Isopropyl alcohol (70% conc.)

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of ingestion, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture woods, animal bites or serious burns

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:30.590268 · Updated: 2026-03-14T23:09:18.179019