drug facts

drug facts

SPL v1

SPL

SPL Set ID a8523a18-317d-99f8-e053-2995a90a7453

Route

topical

Published

Effective Date 2020-03-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

alcohol (350 mL)

Inactive Ingredients

glycerin water carbomer homopolymer, unspecified type trolamine

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-06-01

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.

Active Ingredient

Alcohol

Indications and Usage

For the external use only

Dosage and Administration

Spraying an appropriate amount on your hands or skin and rub it well to dry.

Description

Alcohol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water

Glycerin

Butylene Glycol

Carbomer

Triethanolamine

Mulberry Root Extract

Aloe Extract

Allantoin

Tea Tree Oil

Section 51945-4

Section 55105-1

Antiseptic

Structured Label Content

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.

Active Ingredient (55106-9)

Alcohol

Indications and Usage (34067-9)

For the external use only

Dosage and Administration (34068-7)

Spraying an appropriate amount on your hands or skin and rub it well to dry.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water

Glycerin

Butylene Glycol

Carbomer

Triethanolamine

Mulberry Root Extract

Aloe Extract

Allantoin

Tea Tree Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "350", "strengthDenominator": "500", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For the external use only", "34068-7": "Spraying an appropriate amount on your hands or skin and rub it well to dry.", "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 Butylene Glycol Carbomer Triethanolamine Mulberry Root Extract Aloe Extract Allantoin Tea Tree Oil", "55105-1": "Antiseptic", "55106-9": "Alcohol"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:57.215366 · Updated: 2026-03-14T22:57:17.559926