Hand Sanitizer

SPL v1

SPL

SPL Set ID b56a2a19-fa7c-5acb-e053-2995a90a889d

Route

TOPICAL

Published

Effective Date 2020-12-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Water Ethyl Palmate Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Aminomethylpropanol Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-12-01

Description

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v

Use(s)

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

Section 51945-4

Warnings

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

Directions

Place enough product on hands to cover all surfaces. Rub together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use

in children under 2 months of age

on open wounds

Active Ingredient

Ethyl Alcohol 70% v/v

Other Information

Store between 15-30C (59-86F)

Avoid Freezing and excessive heat above 40C (104F)

Inactive Ingredients

Acrylates Copolymer, Aminomethyl Propanol, Citrus Aurantium Dulcis (Orange) Peel Oil, Ethyl Palmate, Fragrance, Glycerin, Water

When Using This Product

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

Stop Use and Ask A Doctor

if irritation occurs. These may be signs of a serious condition.

Keep Out of Reach of Children.

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

Structured Label Content

Use(s)

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

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

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

Directions

Place enough product on hands to cover all surfaces. Rub together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use (Do not use)

in children under 2 months of age

on open wounds

Active Ingredient

Ethyl Alcohol 70% v/v

Other Information

Store between 15-30C (59-86F)

Avoid Freezing and excessive heat above 40C (104F)

Inactive Ingredients

Acrylates Copolymer, Aminomethyl Propanol, Citrus Aurantium Dulcis (Orange) Peel Oil, Ethyl Palmate, Fragrance, Glycerin, Water

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation occurs. These may be signs of a serious condition.

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": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ETHYL PALMATE", "unii": "PY7890FR5M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)", "unii": "JZ1374NL9E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "Hand Sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from heat or flame.", "Directions": "Place enough product on hands to cover all surfaces. Rub together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.", "Do not use": "in children under 2 months of age on open wounds", "Active Ingredient": "Ethyl Alcohol 70% v/v", "Other Information": "Store between 15-30C (59-86F) Avoid Freezing and excessive heat above 40C (104F)", "Inactive Ingredients": "Acrylates Copolymer, Aminomethyl Propanol, Citrus Aurantium Dulcis (Orange) Peel Oil, Ethyl Palmate, Fragrance, Glycerin, Water", "When using this product": "keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "Stop use and ask a doctor": "if irritation occurs. These may be signs of a serious condition.", "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: 2026-02-15T11:59:06.156060 · Updated: 2026-03-14T22:58:56.195499