b8c9f57e-dd5d-132b-e053-2a95a90a2bef

SPL v1

SPL

SPL Set ID b8c9f57e-dd5d-132b-e053-2a95a90a2bef

Route

topical

Published

Effective Date 2021-01-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (2720 mL)

Inactive Ingredients

water aloe vera leaf hydroxyethyl cellulose, unspecified peppermint oil

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2021-01-13

Purpose

Ethyl Alcohol 68% v/v................Antiseptic

Description

Ethyl Alcohol 68% v/v

Medication Information

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Uses

Hand sanitizer to help reduce bacteria on the skin.

For use when soap and water are not available.

Purpose

Ethyl Alcohol 68% v/v................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 in a cool dry place. Do not overheat.

Inactive Ingredients

Purified Water, Aloe Vera Leaf Juice, Hydroxyethyl Cellulose, Peppermint Oil

Description

Ethyl Alcohol 68% v/v

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

Section 50567-7

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

Section 50570-1

Do not use:

• on children less than 2 months of age

• on open skin wounds

Section 51945-4

Active Ingredient

Ethyl Alcohol 68% v/v

Questions Or Comments?

Call 1-213-235-8072 Monday through Friday, 1pm-5pm PST

Structured Label Content

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Uses

Hand sanitizer to help reduce bacteria on the skin.

For use when soap and water are not available.

Purpose

Ethyl Alcohol 68% v/v................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 in a cool dry place. Do not overheat.

Inactive Ingredients

Purified Water, Aloe Vera Leaf Juice, Hydroxyethyl Cellulose, Peppermint Oil

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use:

• on children less than 2 months of age

• on open skin wounds

Section 51945-4 (51945-4)

Active Ingredient

Ethyl Alcohol 68% v/v

Questions Or Comments? (Questions or Comments?)

Call 1-213-235-8072 Monday through Friday, 1pm-5pm PST

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "2720", "strengthDenominator": "4000", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "HYDROXYETHYL CELLULOSE, UNSPECIFIED", "unii": "T4V6TWG28D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Hand sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.", "50565-1": "Keep out of the reach of children . If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition", "50567-7": "When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "50570-1": "Do not use: • on children less than 2 months of age • on open skin wounds", "Purpose": "Ethyl Alcohol 68% v/v................Antiseptic", "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 children under 6 years of age when using this product to avoid swallowing", "Active Ingredient": "Ethyl Alcohol 68% v/v", "Other Information": "• store in a cool dry place. Do not overheat.", "Inactive Ingredients": "Purified Water, Aloe Vera Leaf Juice, Hydroxyethyl Cellulose, Peppermint Oil", "Questions or Comments?": "Call 1-213-235-8072 Monday through Friday, 1pm-5pm PST"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:16.769581 · Updated: 2026-03-14T22:59:11.576282