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SPL v1

SPL

SPL Set ID a944cc65-72a4-4646-e053-2995a90a3fc3

Route

EXTRACORPOREAL

Published

Effective Date 2020-06-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Isopropyl Alcohol (225 mL)

Inactive Ingredients

Glycerin Water Hydrogen Peroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-06-29

Description

●Store between 15-30°C (59-86°F) ●Avoid freezing and excessive heat above 40°C (104°F)

Medication Information

Warnings and Precautions

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

Indications and Usage

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

2.Supervise children under 6 vears of age when using this product to avoid swallowing.

Dosage and Administration

●Store between 15-30°C (59-86°F)

●Avoid freezing and excessive heat above 40°C (104°F)

Description

●Store between 15-30°C (59-86°F) ●Avoid freezing and excessive heat above 40°C (104°F)

Section 50565-1

keep out of reach of children

Section 51727-6

Glycerin，hydrogen peroxide，purified water USP

Section 51945-4

Section 55105-1

Disinfection

Sterilization

No Rinseing

Section 55106-9

isopropyl alcohol

Structured Label Content

Indications and Usage (34067-9)

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

2.Supervise children under 6 vears of age when using this product to avoid swallowing.

Dosage and Administration (34068-7)

●Store between 15-30°C (59-86°F)

●Avoid freezing and excessive heat above 40°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)

Glycerin，hydrogen peroxide，purified water USP

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Disinfection

Sterilization

No Rinseing

Section 55106-9 (55106-9)

isopropyl alcohol

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "225", "strengthDenominator": "300", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "1.Place enough product on hands to cover all surfaces. Rub hands together until dry. 2.Supervise children under 6 vears of age when using this product to avoid swallowing.", "34068-7": "●Store between 15-30°C (59-86°F) ●Avoid freezing and excessive heat above 40°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": "Glycerin，hydrogen peroxide，purified water USP", "55105-1": "Disinfection Sterilization No Rinseing", "55106-9": "isopropyl alcohol"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:04.487714 · Updated: 2026-03-14T22:57:27.471846