Total Pure Alcohol Based Hand Sanitizer

SPL v3

SPL

SPL Set ID a6147052-04cd-33ce-e053-2995a90a6998

Route

TOPICAL

Published

Effective Date 2020-05-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.25 mL)

Inactive Ingredients

Carbomer 940 Trolamine Water Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-29

Description

Ethyl Alcohol 70% v/v

Indications and Usage

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

Purpose

Antimicrobial

Medication Information

Indications and Usage

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

Purpose

Antimicrobial

Description

Ethyl Alcohol 70% v/v

Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts.

Warnings

Flammable

Keep away from heat or flame.

For external use only.

Directions

Directions

• Place enough product in your palm to cover hands and rub hands together briskly until dry.

• Children under 6 years of age should be surpervised when using this product.

Active Ingredient

Ethyl Alcohol 70% v/v

Inactive Ingredients

Water, Carbomer, Triethanolamine. and Glycerine

Principal Display Panel

500ML NDC: 51384-003-002

When Using This Product

When using this product

Do not use near or in the eyes.

In case of contact, rinse eyes thoroughly with water.

Keep Out of Reach Section

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Purpose (PURPOSE)

Antimicrobial

Stop Use (Stop use)

Stop use and ask a doctor if irritation or rash appears and lasts.

Warnings (WARNINGS)

Flammable

Keep away from heat or flame.

For external use only.

Directions

Directions

• Place enough product in your palm to cover hands and rub hands together briskly until dry.

• Children under 6 years of age should be surpervised when using this product.

Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 70% v/v

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Carbomer, Triethanolamine. and Glycerine

Indications and Usage (INDICATIONS AND USAGE)

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

Principal Display Panel

500ML NDC: 51384-003-002

When Using This Product (When using this product)

When using this product

Do not use near or in the eyes.

In case of contact, rinse eyes thoroughly with water.

Keep Out of Reach Section (KEEP OUT OF REACH SECTION)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "0.25", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "0.25", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "29.3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"PURPOSE": "Antimicrobial", "Stop use": "Stop use and ask a doctor if irritation or rash appears and lasts.", "WARNINGS": "Flammable Keep away from heat or flame. For external use only.", "Directions": "Directions • Place enough product in your palm to cover hands and rub hands together briskly until dry. • Children under 6 years of age should be surpervised when using this product.", "ACTIVE INGREDIENT": "Ethyl Alcohol 70% v/v", "INACTIVE INGREDIENTS": "Water, Carbomer, Triethanolamine. and Glycerine", "INDICATIONS AND USAGE": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "Principal Display Panel": "500ML NDC: 51384-003-002", "When using this product": "When using this product Do not use near or in the eyes. In case of contact, rinse eyes thoroughly with water.", "KEEP OUT OF REACH SECTION": "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: 2026-02-15T11:57:57.147383 · Updated: 2026-03-14T22:57:15.604123