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

Description

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

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

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.

Structured Label Content

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)

Purpose (PURPOSE)

Antiseptic

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.

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 (ACTIVE INGREDIENT)

Ethyl Alcohol 70% v/v

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

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:57:34.191329 · Updated: 2026-03-14T22:56:48.082967