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SPL v1

SPL

SPL Set ID ac1b4bac-0ced-3d0e-e053-2995a90a1815

Route

TOPICAL

Published

Effective Date 2020-04-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Glycerin Carbomer Homopolymer, Unspecified Type Water Trolamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-07-20

Description

Alcohol

Medication Information

Warnings and Precautions

For external use only.

Flammable. Keep away from fire or flame.

Do not use in eyes.

If swallowed, get medical help promptly.

Stop use, ask doctor if irritation occurs.

Keep out of reach of children.

Indications and Usage

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

Dosage and Administration

For external only

Description

Alcohol

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 51727-6

Water

Glycerin

Butylene Glycol

Carbomer

Triethanolamine

Mulberry Root Extract

Aloe Extract

Allantoin

Fragrance

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Alcohol

Structured Label Content

Indications and Usage (34067-9)

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

Dosage and Administration (34068-7)

For external only

Warnings and Precautions (34071-1)

For external use only.

Flammable. Keep away from fire or flame.

Do not use in eyes.

If swallowed, get medical help promptly.

Stop use, ask doctor if irritation occurs.

Keep out of reach of children.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 51727-6 (51727-6)

Water

Glycerin

Butylene Glycol

Carbomer

Triethanolamine

Mulberry Root Extract

Aloe Extract

Allantoin

Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Alcohol

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "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": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry. Supervise children in the use of this product.", "34068-7": "For external only", "34071-1": "For external use only. Flammable. Keep away from fire or flame. Do not use in eyes. If swallowed, get medical help promptly. Stop use, ask doctor if irritation occurs. Keep out of reach of children.", "50565-1": "KEEP OUT OF REACH OF CHILDREN", "51727-6": "Water Glycerin Butylene Glycol Carbomer Triethanolamine Mulberry Root Extract Aloe Extract Allantoin Fragrance", "55105-1": "Antiseptic", "55106-9": "Alcohol"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:24.872951 · Updated: 2026-03-14T22:57:55.937889