Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID a3004601-e9e5-7cd5-e053-2995a90a1343

Route

TOPICAL

Published

Effective Date 2020-04-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (75.9 mL)

Inactive Ingredients

Carbomer 940 Trolamine Water Dipropylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-01

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.

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

ethyl alcohol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

water, trolamine, dipropylene glycol, carbomer

Section 51945-4

Section 55105-1

to decrease bacteria on the skin that could cause disease

recommended for repeated use

Section 55106-9

ethyl alcohol

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, trolamine, dipropylene glycol, carbomer

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

to decrease bacteria on the skin that could cause disease

recommended for repeated use

Section 55106-9 (55106-9)

ethyl alcohol

Advanced Ingredient Data

[{"name": "CARBOMER 940", "unii": "4Q93RCW27E", "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": "75.9", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "DIPROPYLENE GLYCOL", "unii": "E107L85C40", "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, trolamine, dipropylene glycol, carbomer", "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: 2026-02-15T11:57:11.938984 · Updated: 2026-03-14T22:56:09.845676