Hand Sanitizer

SPL v1

SPL

SPL Set ID aa63a9fe-522e-63ec-e053-2995a90a8567

Route

TOPICAL

Published

Effective Date 2020-05-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Hydrogen Peroxide Glycerin Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-28

Description

Ethyl Alcohol 75%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%

Use

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

Stop Use

Stop use and ask a doctor if irritation or rash occurs.

These rnay be signs of a serious condition.

Warnings

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

Directions

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

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

Do Not Use

in children less than 2 rnonths of age

on open skin worunds

Other Information

Store between 15-30°C(59-86F)

Avoid freezing and excessive heat above 40°C(104F)

When Using Section

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

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Keep Out of Reach of Children

Keep out of reach of children.

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

Package Label Principal Display Panel

Structured Label Content

Use

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

Purpose

Antiseptic

Stop Use (STOP USE)

Stop use and ask a doctor if irritation or rash occurs.

These rnay be signs of a serious condition.

Warnings

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

Directions

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

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

Do Not Use (Do not use)

in children less than 2 rnonths of age

on open skin worunds

Other Information (Other information)

Store between 15-30°C(59-86F)

Avoid freezing and excessive heat above 40°C(104F)

When Using Section (WHEN USING SECTION)

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

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients (Inactive ingredients)

glycerin, hydrogen peroxide, purified water USP

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

Keep out of reach of children.

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

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

[{"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand sanitizer to help reduce bacteria that poterntially can cuase disease. For use when soap and water are not available.", "Purpose": "Antiseptic", "STOP USE": "Stop use and ask a doctor if irritation or rash occurs. These rnay be signs of a serious condition.", "Warnings": "For external use only. Flammable. Keep away from heat or flame.", "Directions": "Place enough product on hands to cover all surfaces, Rub hands together until dry. Supervise clhildren under 6 years of age when using this product to avoid swallowing.", "Do not use": "in children less than 2 rnonths of age on open skin worunds", "Other information": "Store between 15-30°C(59-86F) Avoid freezing and excessive heat above 40°C(104F)", "WHEN USING SECTION": "keep out of eyes.ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "Active Ingredient(s)": "Ethyl Alcohol 75%", "Inactive ingredients": "glycerin, hydrogen peroxide, purified water USP", "Keep out of reach of children": "Keep out of reach of children. If swallowed. get medical help or contact a Posion Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:11.923983 · Updated: 2026-03-14T22:57:38.360001