Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID a2d65bdd-4525-1a2e-e053-2995a90aa283

Route

TOPICAL

Published

Effective Date 2020-03-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (62 g)

Inactive Ingredients

Butylene Glycol Water Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-01

Description

Alcohol

Medication Information

Warnings and Precautions

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Store under 30°C (86°F)

Dosage and Administration

Put enough product in your palm to thoroughly cover your hands
Rub hands together briskly until dry
Children under 6 years of age should be supervised when using this product

Description

Alcohol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water, Glycerin, Carbomer, Butylene Glycol, etc.

Section 51945-4

Section 55105-1

Antimicrobial

Section 55106-9

Alcohol

Structured Label Content

Indications and Usage (34067-9)

Store under 30°C (86°F)

Dosage and Administration (34068-7)

Put enough product in your palm to thoroughly cover your hands
Rub hands together briskly until dry
Children under 6 years of age should be supervised when using this product

Warnings and Precautions (34071-1)

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water, Glycerin, Carbomer, Butylene Glycol, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antimicrobial

Section 55106-9 (55106-9)

Alcohol

Advanced Ingredient Data

[{"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Store under 30°C (86°F)", "34068-7": "Put enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry Children under 6 years of age should be supervised when using this product", "34071-1": "For external use only. Flammable, keep away from fire or flame. When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water. Stop use and ask a doctor if significant irritation or sensitization develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50565-1": "KEEP OUT OF REACH OF THE CHILDREN", "51727-6": "Water, Glycerin, Carbomer, Butylene Glycol, etc.", "55105-1": "Antimicrobial", "55106-9": "Alcohol"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:10.253514 · Updated: 2026-03-14T22:56:08.503602