drug facts

drug facts

SPL v2

SPL

SPL Set ID a198033e-fa74-35eb-e053-2a95a90a0e13

Route

topical

Published

Effective Date 2020-05-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

alcohol (62 g)

Inactive Ingredients

glycerin trolamine water polysorbate 80

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-03-21

Purpose

Antiseptic

Description

Ethyl alcohol 62%

Medication Information

Warnings

■ For external use only.

■ Flammable. ■ Keep away from heat and Flame.

When using this product

■ Keep out of eyes, ears and mouth.

■ If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor

■ If irritation and rash occurs.

Uses

Hand sanitizer to help reduce bacteria on the skin. Only when water and soap is not available.

Purpose

Antiseptic

Directions

■ Wet hands thoroughly with product and rub hands together until dry.

■ Supervise children under 6 years of age when using.

Inactive Ingredients

Water, Glycerin, Carbomer, Triethanolamine, Polysorbate 80

Description

Ethyl alcohol 62%

Active Ingredient

Ethyl alcohol 62%

Keep Out of Reach of Children

■ lf swallowed, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel

Structured Label Content

Warnings (WARNINGS)

■ For external use only.

■ Flammable. ■ Keep away from heat and Flame.

When using this product

■ Keep out of eyes, ears and mouth.

■ If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor

■ If irritation and rash occurs.

Uses

Hand sanitizer to help reduce bacteria on the skin. Only when water and soap is not available.

Purpose (PURPOSE)

Antiseptic

Directions

■ Wet hands thoroughly with product and rub hands together until dry.

■ Supervise children under 6 years of age when using.

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Glycerin, Carbomer, Triethanolamine, Polysorbate 80

Active Ingredient (ACTIVE INGREDIENT)

Ethyl alcohol 62%

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

■ lf swallowed, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Hand sanitizer to help reduce bacteria on the skin. Only when water and soap is not available.", "PURPOSE": "Antiseptic", "WARNINGS": "■ For external use only. ■ Flammable. ■ Keep away from heat and Flame. When using this product ■ Keep out of eyes, ears and mouth. ■ If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor ■ If irritation and rash occurs.", "Directions": "■ Wet hands thoroughly with product and rub hands together until dry. ■ Supervise children under 6 years of age when using.", "ACTIVE INGREDIENT": "Ethyl alcohol 62%", "INACTIVE INGREDIENTS": "Water, Glycerin, Carbomer, Triethanolamine, Polysorbate 80", "KEEP OUT OF REACH OF CHILDREN": "■ lf swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:41.634501 · Updated: 2026-03-14T22:56:56.523889