drug facts

drug facts

SPL v1

SPL

SPL Set ID 0feaf9f3-35ee-4a3f-9246-ba697e040a0b

Route

topical

Published

Effective Date 2020-05-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

alcohol (350 mL)

Inactive Ingredients

water glycerin carbomer homopolymer, unspecified type trolamine

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-05-01

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v

Medication Information

Warnings

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

Do not use

• in children 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 with eyes, 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

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.

Other Information

• Store between 15-30C (59-86F)

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

Inactive Ingredients

Water, Glycerin, Carbomer, Trolamine, Fragrance

Description

Ethyl Alcohol 70% v/v

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available

Section 51945-4

Active Ingredient

Ethyl Alcohol 70% 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 (WARNINGS)

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

Do not use

• in children 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 with eyes, 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

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.

Other Information (Other information)

• Store between 15-30C (59-86F)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Glycerin, Carbomer, Trolamine, Fragrance

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available

Section 51945-4 (51945-4)

Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 70% 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": "350", "strengthDenominator": "500", "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": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Trolamine", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses:": "Hand sanitizer to help reduce bacteria that potentially can 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 Do not use • in children 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 with eyes, 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": "Ethyl Alcohol 70% v/v", "Other information": "• Store between 15-30C (59-86F) • Avoid freezing and excessive heat above 40C (104F)", "INACTIVE INGREDIENTS": "Water, Glycerin, Carbomer, Trolamine, Fragrance", "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: 2026-02-15T11:57:34.191329 · Updated: 2026-03-14T22:56:48.082967