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SPL v2

SPL

SPL Set ID a9bf73d9-9eb2-5e12-e053-2995a90a0332

Route

TOPICAL

Published

Effective Date 2020-07-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-07-06

Description

Ethyl Alcohol 75.0%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 75.0%

Uses

for handwashing to decrease bacteria on the skin
recommended for repeated use

Label

Section 50565-1

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

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%

Other Information

store at 20C to 25C (68 to 77F)
may discolor certain fabrics.

Inactive Ingredient

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 persist for more than 72 hours.

Structured Label Content

Uses

for handwashing to decrease bacteria on the skin
recommended for repeated use

Label

Section 50565-1 (50565-1)

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

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)

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Active Ingredient

Ethyl Alcohol 75.0%

Other Information (Other information)

store at 20C to 25C (68 to 77F)
may discolor certain fabrics.

Inactive Ingredient (Inactive ingredient)

Water

Glycerin

Carbomer

Aloe Vera

triethanolamine

Vitamin E

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

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Advanced Ingredient Data

[{"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "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": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "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", "50565-1": "If swallowed, get medical help or contact a Posion Control Center right away.", "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%", "Other information": "store at 20C to 25C (68 to 77F) may discolor certain fabrics.", "Inactive ingredient": "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 persist for more than 72 hours."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:06.984021 · Updated: 2026-03-14T23:12:15.627416