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SPL v2

SPL

SPL Set ID b2cabb5d-9302-2d2a-e053-2995a90a6a9a

Route

TOPICAL

Published

Effective Date 2020-10-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (45 mL)

Inactive Ingredients

Glycerin Trolamine Water Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-10-29

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

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 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 50570-1

1.ln children less than 2 months of age.

2.On open skin wounds.

Section 51727-6

Carbomer

Glycerol

Triethanolamine

Water

Section 51945-4

Section 55105-1

Disinfection

Sterilization

Section 55106-9

Alcohol

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 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 50570-1 (50570-1)

1.ln children less than 2 months of age.

2.On open skin wounds.

Section 51727-6 (51727-6)

Carbomer

Glycerol

Triethanolamine

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Disinfection

Sterilization

Section 55106-9 (55106-9)

Alcohol

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "45", "strengthDenominator": "60", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "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 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", "50570-1": "1.ln children less than 2 months of age. 2.On open skin wounds.", "51727-6": "Carbomer Glycerol Triethanolamine Water", "55105-1": "Disinfection Sterilization", "55106-9": "Alcohol"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:13.863317 · Updated: 2026-03-14T23:00:36.247175