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

Description

Ethyl alcohol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 62%

Uses

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

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.

Package Label.principal Display Panel

Structured Label Content

Uses

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

Purpose (PURPOSE)

Antiseptic

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.

Directions

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

■ Supervise children under 6 years of age when using.

Active Ingredient (ACTIVE INGREDIENT)

Ethyl alcohol 62%

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Glycerin, Carbomer, Triethanolamine, Polysorbate 80

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