SPL v1
SPL
SPL Set ID 2b473779-4e94-40d1-938d-b7e46501e4b5
Route
TOPICAL
Published
Effective Date 2020-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Glycerin Trolamine Aminomethylpropanol Denatonium Benzoate Tert-butyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-27
Description

Alcohol 75% v/v

Purpose

antiseptic

Medication Information

Purpose

antiseptic

Description

Alcohol 75% v/v

use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5

other information

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

For external use only.

Flammable, Keep away from heat or flame.

Do not use

  • Onchildren less than 2 months of age
  • On open skin wounds

When using this product

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

Stop use and ask a doctor if

irritation or rash occurs. These may be signs of a serious condition.

Packaging

directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Active Ingredient

Alcohol 75% v/v

Inactive Ingredients

Purified Water USP, Acrylates Copolymer, Glycerin, Triethanolamine, Aminomethyl Propanol, Denatonium Benzoate, Tert-butyl Alcohol

Keep Out of Reach of Children.

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

Structured Label Content

use (Use)

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5 (42229-5)

other information

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

antiseptic

Warnings

For external use only.

Flammable, Keep away from heat or flame.

Do not use

  • Onchildren less than 2 months of age
  • On open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact, rinse eyes 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)
  • Place enough product on hands to cover all surfaces. Rub hands together until dry
  • 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)

Purified Water USP, Acrylates Copolymer, Glycerin, Triethanolamine, Aminomethyl Propanol, Denatonium Benzoate, Tert-butyl Alcohol

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: 2026-02-15T11:58:33.621184 · Updated: 2026-03-14T22:58:10.333472