Hand Sanitizer

SPL v1

SPL

SPL Set ID a686f01c-4346-6371-e053-2995a90a2c3b

Route

TOPICAL

Published

Effective Date 2020-05-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Glycerin Carbomer Homopolymer, Unspecified Type Aloe Vera Leaf Trolamine Water .alpha.-tocopherol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-16

Description

Ethyl Alcohol 75.0%v/v

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 75.0%v/v

Uses

for handwashing to decrease bacteria on the skin.

recommended for repeated use.

Warnings

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

Directions

wet hands thoroughly with product briskly rub hands together until dry. Supervise children under 6 years in the use of this product.

Do Not Use

in the eyes.In case of contact,rinse eyes thoroughly with water.

Active Ingredient

Ethyl Alcohol 75.0%v/v

Other Information

store at 20℃ to 25℃(68° to 77°F）

may discolor certain fabrics.

Inactive Ingredients

Water,Glycerin, Carbomer,Aloe Vera,Triethanolamine,Vitamin E.

Stop Use and Ask A Doctor If

irritation and redness develop and persistfor more than 72 hours.

Keep Out of Reach for Children

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

Package Label Principal Display Panel

Structured Label Content

Uses

for handwashing to decrease bacteria on the skin.

recommended for repeated use.

Purpose

Antimicrobial

Warnings

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

Directions

wet hands thoroughly with product briskly rub hands together until dry. Supervise children under 6 years in the use of this product.

Do Not Use (Do not use)

in the eyes.In case of contact,rinse eyes thoroughly with water.

Active Ingredient

Ethyl Alcohol 75.0%v/v

Other Information

store at 20℃ to 25℃(68° to 77°F）

may discolor certain fabrics.

Inactive Ingredients (Inactive ingredients)

Water,Glycerin, Carbomer,Aloe Vera,Triethanolamine,Vitamin E.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation and redness develop and persistfor more than 72 hours.

Keep Out of Reach for Children (Keep out of reach for children)

If 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": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "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": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for handwashing to decrease bacteria on the skin. recommended for repeated use.", "Purpose": "Antimicrobial", "Warnings": "For external use only.Flammable. Keep away from heat and flame.", "Directions": "wet hands thoroughly with product briskly rub hands together until dry. Supervise children under 6 years in the use of this product.", "Do not use": "in the eyes.In case of contact,rinse eyes thoroughly with water.", "Active Ingredient": "Ethyl Alcohol 75.0%v/v", "Other Information": "store at 20℃ to 25℃(68° to 77°F） may discolor certain fabrics.", "Inactive ingredients": "Water,Glycerin, Carbomer,Aloe Vera,Triethanolamine,Vitamin E.", "Stop use and ask a doctor if": "irritation and redness develop and persistfor more than 72 hours.", "Keep out of reach for children": "If swallowed,get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:42.665429 · Updated: 2026-03-14T22:56:57.656663