SPL v1
SPL
SPL Set ID fbb45bde-b733-4524-bfa9-ae819ad39973
Route
TOPICAL
Published
Effective Date 2026-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (50 mL)
Inactive Ingredients
Water Fd&c Green No. 3 Fd&c Yellow No. 5 Methyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-20

Description

Isopropyl Alcohol 50%

Purpose

FIRST AID ANTISEPTIC


Medication Information

Purpose

FIRST AID ANTISEPTIC

Description

Isopropyl Alcohol 50%

Uses

First aid to help prevent the risk of infection in minor cuts, Scrapes & Burns.

Section 50565-1

Warnings
  • For external use only
  • IF taken internally, Serious gastric disturbances will result.  Flammable, keep away from heat or flame.
  • Use only in a well-ventilated area:Fumes may be toxic.

Ask a doctor before use if you havedeep or puncture wounds, Animal bites or serious burns.

When using this product:

  • Do not get in the eyes
  • Do not inhale
  • Do not apply over large areas of the body
  • Do not use longer than one week unless directed by doctor

Stop use and ask doctor ifconditions persist or get worse

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

Directions
  • Clean the affected Area
  • Apply small amount of this product on the area 1-3 times daily
  • Let the alcohol dry on skin before using bandages.
  • May be covered with a sterile bandag.
Product Label

Active Ingredient

Isopropyl Alcohol 50%

Other Information
  • Store ate room temperature
  • Does not contain, nor is intended as a substitute for grain or ethyl alchol.
Inactive Ingredients

FD&C Green #3, FD&C Yellow #5, methyl salicylate, purified water


Structured Label Content

Uses

First aid to help prevent the risk of infection in minor cuts, Scrapes & Burns.

Section 50565-1 (50565-1)

Purpose

FIRST AID ANTISEPTIC

Warnings
  • For external use only
  • IF taken internally, Serious gastric disturbances will result.  Flammable, keep away from heat or flame.
  • Use only in a well-ventilated area:Fumes may be toxic.

Ask a doctor before use if you havedeep or puncture wounds, Animal bites or serious burns.

When using this product:

  • Do not get in the eyes
  • Do not inhale
  • Do not apply over large areas of the body
  • Do not use longer than one week unless directed by doctor

Stop use and ask doctor ifconditions persist or get worse

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

Directions
  • Clean the affected Area
  • Apply small amount of this product on the area 1-3 times daily
  • Let the alcohol dry on skin before using bandages.
  • May be covered with a sterile bandag.
Product Label (Product label)

Active Ingredient

Isopropyl Alcohol 50%

Other Information (Other information)
  • Store ate room temperature
  • Does not contain, nor is intended as a substitute for grain or ethyl alchol.
Inactive Ingredients

FD&C Green #3, FD&C Yellow #5, methyl salicylate, purified water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)