drug facts

drug facts

SPL v1

SPL

SPL Set ID a9310d2f-4424-1267-e053-2995a90ada75

Route

topical

Published

Effective Date 2020-06-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

alcohol (75 mL)

Inactive Ingredients

trolamine water glycerin carbomer 940

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-06-29

Description

ethyl alcohol

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.

Active Ingredient

ethyl alcohol

Indications and Usage

■ Wet hands thoroughly with product and allow to dry without wiping

■ Do not flush

■ Children under 2 years ask a doctor before use

Dosage and Administration

for external use only

Description

ethyl alcohol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water, Glycerin, Fragrance, Carbomer, Trolamine

Section 51945-4

Section 55105-1

to decrease bacteria on the skin that could cause disease

recommended for repeated use

Structured Label Content

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.

Active Ingredient (55106-9)

ethyl alcohol

Indications and Usage (34067-9)

■ Wet hands thoroughly with product and allow to dry without wiping

■ Do not flush

■ Children under 2 years ask a doctor before use

Dosage and Administration (34068-7)

for external use only

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water, Glycerin, Fragrance, Carbomer, Trolamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

to decrease bacteria on the skin that could cause disease

recommended for repeated use

Advanced Ingredient Data

[{"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": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "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 ■ Do not flush ■ Children under 2 years ask a doctor before use", "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, Glycerin, Fragrance, Carbomer, Trolamine", "55105-1": "to decrease bacteria on the skin that could cause disease recommended for repeated use", "55106-9": "ethyl alcohol"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:58:04.400727 · Updated: 2026-03-14T22:57:25.927839