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SPL v1

SPL

SPL Set ID a1b2673a-51dd-35e4-e053-2a95a90aaeab

Route

TOPICAL

Published

Effective Date 2020-03-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.125 mL)

Inactive Ingredients

Hydrogen Peroxide Glycerin Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-27

Description

ALCOHOL 80% V/V. PURPOSE: ANTISEPTIC

Medication Information

Warnings and Precautions

Warnings: For external use only. Flammable. Kepp away from heat or flame.

Indications and Usage

Use(s): Hand santitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and Administration

Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry.

Description

ALCOHOL 80% V/V. PURPOSE: ANTISEPTIC

Section 50565-1

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

Section 51727-6

Inactive Ingredients: glycerin, hydrogen peroxide, purified water USP

Section 51945-4

3785mL 74105-900-01

Hand Sanitizer Gallon.jpg

Section 55105-1

ANTISEPTIC

Section 55106-9

ALCOHOL 80% V/V. PURPOSE: ANTISEPTIC

Structured Label Content

Indications and Usage (34067-9)

Use(s): Hand santitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and Administration (34068-7)

Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry.

Warnings and Precautions (34071-1)

Warnings: For external use only. Flammable. Kepp away from heat or flame.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive Ingredients: glycerin, hydrogen peroxide, purified water USP

Section 51945-4 (51945-4)

3785mL 74105-900-01

Hand Sanitizer Gallon.jpg

Section 55105-1 (55105-1)

ANTISEPTIC

Section 55106-9 (55106-9)

ALCOHOL 80% V/V. PURPOSE: ANTISEPTIC

Advanced Ingredient Data

[{"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "0.125", "strengthDenominator": "80", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "80", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "1.45", "strengthDenominator": "80", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use(s): Hand santitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "34068-7": "Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry.", "34071-1": "Warnings: For external use only. Flammable. Kepp away from heat or flame.", "50565-1": "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive Ingredients: glycerin, hydrogen peroxide, purified water USP", "51945-4": "3785mL 74105-900-01 Hand Sanitizer Gallon.jpg", "55105-1": "ANTISEPTIC", "55106-9": "ALCOHOL 80% V/V. PURPOSE: ANTISEPTIC"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:30.451716 · Updated: 2026-03-14T22:56:42.417712