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SPL v1

SPL

SPL Set ID a70156e5-52df-07f4-e053-2a95a90a8300

Route

TOPICAL

Published

Effective Date 2020-05-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (400 mL)

Inactive Ingredients

Water Hydrogen Peroxide Glycerin Tert-butyl Alcohol Denatonium Benzoate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-14

Description

Store between 15-30°C(59-86°F) Avoid feezing and excessive heat above40°C (104°F)

Medication Information

Warnings and Precautions

For external use only.Flammable. Keep away from heat or flame.

Indications and Usage

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

Dosage and Administration

Store between 15-30°C(59-86°F)

Avoid feezing and excessive heat above40°C (104°F)

Description

Store between 15-30°C(59-86°F) Avoid feezing and excessive heat above40°C (104°F)

Section 50565-1

keep out of reach of children

Section 51727-6

Water

Glycerin

Hydrogen Peroxide

Tert-butyl alcohol

Denatonium benzoate

Section 51945-4

Section 55105-1

Disinfection

Sterilization

No Rinseing

Section 55106-9

Ethanol

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Store between 15-30°C(59-86°F)

Avoid feezing and excessive heat above40°C (104°F)

Warnings and Precautions (34071-1)

For external use only.Flammable. Keep away from heat or flame.

Section 50565-1 (50565-1)

keep out of reach of children

Section 51727-6 (51727-6)

Water

Glycerin

Hydrogen Peroxide

Tert-butyl alcohol

Denatonium benzoate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Disinfection

Sterilization

No Rinseing

Section 55106-9 (55106-9)

Ethanol

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "500", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TERT-BUTYL ALCOHOL", "unii": "MD83SFE959", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DENATONIUM BENZOATE", "unii": "4YK5Z54AT2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Place enough product on hands to cover all surfaces.Rub hands together until dry.", "34068-7": "Store between 15-30°C(59-86°F) Avoid feezing and excessive heat above40°C (104°F)", "34071-1": "For external use only.Flammable. Keep away from heat or flame.", "50565-1": "keep out of reach of children", "51727-6": "Water Glycerin Hydrogen Peroxide Tert-butyl alcohol Denatonium benzoate", "55105-1": "Disinfection Sterilization No Rinseing", "55106-9": "Ethanol"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:46.342823 · Updated: 2026-03-14T22:57:01.531445