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
Purpose

First aid antiseptic

Description

Isopropyl alcohol (70% conc.)

Medication Information

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
Uses

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

Purpose

First aid antiseptic

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
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

Description

Isopropyl alcohol (70% conc.)

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

Package Label
LEADER Isopropyl Alcohol 70% Wintergreen
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

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
Uses

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

Purpose

First aid antiseptic

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
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

Package Label
LEADER Isopropyl Alcohol 70% Wintergreen
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