Hand Sanitizer

SPL v1

SPL

SPL Set ID e9c9aebe-987e-4ff0-a70f-0adb919e8a16

Route

TOPICAL

Published

Effective Date 2020-07-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Glycerin Aminomethylpropanol Carbomer Homopolymer, Unspecified Type Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-07-15

Description

Ethyl Alcohol 70%

Medication Information

Indications and Usage

Description

Ethyl Alcohol 70%

Pupose

Antimicrobial

Section 50565-1

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not ingest, if swallowed seek medical help. Avoid contact with eyes.

Keep out of reach of children.

Children under 6 years old to use under adult supervision. In case of irritation, discontinue use and consult your doctor.

May discolor certain fabrics or surfaces. Store below 106°F

Directions

Apply the gel on the hands and rub gently for 20 seconds until the product evaporates

Product Label

Active Ingredient

Ethyl Alcohol 70%

Inactive Ingredients

Distilled Water, Glycerin, Carbomer, Aminomethyl propanol, Fragrance

Structured Label Content

Pupose

Antimicrobial

Indications and Usage (34067-9)

Section 50565-1 (50565-1)

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not ingest, if swallowed seek medical help. Avoid contact with eyes.

Keep out of reach of children.

Children under 6 years old to use under adult supervision. In case of irritation, discontinue use and consult your doctor.

May discolor certain fabrics or surfaces. Store below 106°F

Directions

Apply the gel on the hands and rub gently for 20 seconds until the product evaporates

Product Label

Active Ingredient

Ethyl Alcohol 70%

Inactive Ingredients

Distilled Water, Glycerin, Carbomer, Aminomethyl propanol, Fragrance

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Pupose": "Antimicrobial", "Warnings": "For external use only. Flammable. Keep away from heat or flame Do not ingest, if swallowed seek medical help. Avoid contact with eyes. Keep out of reach of children. Children under 6 years old to use under adult supervision. In case of irritation, discontinue use and consult your doctor. May discolor certain fabrics or surfaces. Store below 106°F", "Directions": "Apply the gel on the hands and rub gently for 20 seconds until the product evaporates", "Active Ingredient": "Ethyl Alcohol 70%", "Inactive Ingredients": "Distilled Water, Glycerin, Carbomer, Aminomethyl propanol, Fragrance"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:13.560365 · Updated: 2026-03-14T22:57:40.950905