SPL v1
SPL
SPL Set ID 9cfde502-9c55-4b8b-b2a9-de0a63d9342e
Route
TOPICAL
Published
Effective Date 2020-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Glycerin Denatonium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-18
Description

Alcohol 75% v/v

Purpose

 Antiseptic

Medication Information

Purpose

 Antiseptic

Description

Alcohol 75% v/v

use

Sanitizing disinfectant to help reduce bacteria that potentially can cause disease. For use when soap ad water are not avilable.

Section 42229-5

Other information

  • Store between 59-86℉ (15-30℃)
  • Avoid freezing and excessive heat above 104℉ (40℃)
Warnings

For external use only.

Flammable,

Keep away from heat and flame.

Do not use

  • On children less than 2 months of age 
  • On broken skin.

When using this product keep out of eyes, ears, and mouth. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if  irritation or rash occurs. These may be signs of a serious condition.

Packaging

directions
  • For best results apply a generous amount to a clean cloth and thoroughly clean areas that need to be disinfectant.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Active Ingredient

Alcohol 75% v/v

Inactive Ingredients

Water USP, Denatonium Benzoate.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

use (Use)

Sanitizing disinfectant to help reduce bacteria that potentially can cause disease. For use when soap ad water are not avilable.

Section 42229-5 (42229-5)

Other information

  • Store between 59-86℉ (15-30℃)
  • Avoid freezing and excessive heat above 104℉ (40℃)
Purpose

 Antiseptic

Warnings

For external use only.

Flammable,

Keep away from heat and flame.

Do not use

  • On children less than 2 months of age 
  • On broken skin.

When using this product keep out of eyes, ears, and mouth. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if  irritation or rash occurs. These may be signs of a serious condition.

Packaging

directions (Directions)
  • For best results apply a generous amount to a clean cloth and thoroughly clean areas that need to be disinfectant.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Active Ingredient (Active ingredient)

Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Water USP, Denatonium Benzoate.

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

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:57.134284 · Updated: 2026-03-14T22:57:15.604123