2b473779-4e94-40d1-938d-b7e46501e4b5

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

Purpose

antiseptic

Description

Alcohol 75% v/v

Medication Information

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.

Purpose

antiseptic

Inactive Ingredients

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

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℉)

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

Keep Out of Reach of Children.

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

Structured Label Content

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.

Purpose (purpose)

antiseptic

Inactive Ingredients (Inactive ingredients)

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

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℉)

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

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

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DENATONIUM BENZOATE", "unii": "4YK5Z54AT2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TERT-BUTYL ALCOHOL", "unii": "MD83SFE959", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "42229-5": "other information Store between 15-30℃ (59-86 ℉) Avoid freezing and excessive heat above 40℃(104℉)", "purpose": "antiseptic", "Warnings": "For external use only. Flammable , Keep away from heat or flame. Do not use On children less than 2 months of age On open skin wounds When using this product keep out of eye s, 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.", "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."}

Additional Information

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