Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID af43a3c5-fff0-66ce-e053-2a95a90a8e43

Route

TOPICAL

Published

Effective Date 2020-05-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (54.7 mL)

Inactive Ingredients

Glycerin Water Trolamine Butylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-22

Description

ethanol

Medication Information

Warnings and Precautions

■ Flammable. Keep away from fire or flame.

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

Indications and Usage

wet hands thoroughly with product and allow to dry without wiping

for children under 6, use only under adult supervision

not recommended for infants

Dosage and Administration

for external use only

Description

ethanol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water, Alcohol,Butylene Glycol,

Polyoxyethylene, Glycerin, Carbomer, Fragrance, Triethanolamine

Section 51945-4

Section 55105-1

■ sterilization of hands and skin

Section 55106-9

ethanol

Structured Label Content

Indications and Usage (34067-9)

wet hands thoroughly with product and allow to dry without wiping

for children under 6, use only under adult supervision

not recommended for infants

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

■ Flammable. Keep away from fire or flame.

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water, Alcohol,Butylene Glycol,

Polyoxyethylene, Glycerin, Carbomer, Fragrance, Triethanolamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

■ sterilization of hands and skin

Section 55106-9 (55106-9)

ethanol

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "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": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "54.7", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision not recommended for infants", "34068-7": "for external use only", "34071-1": "■ Flammable. Keep away from fire or flame. ■ For external use only. ■ Do not use in eyes. ■ lf swallowed, get medical help promptly. ■ Stop use, ask doctor lf irritation occurs. ■ Keep out of reach of children.", "50565-1": "KEEP OUT OF REACH OF THE CHILDREN", "51727-6": "Water, Alcohol,Butylene Glycol, Polyoxyethylene, Glycerin, Carbomer, Fragrance, Triethanolamine", "55105-1": "■ sterilization of hands and skin", "55106-9": "ethanol"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:58:43.980893 · Updated: 2026-03-14T22:58:26.649878