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SPL v1

SPL

SPL Set ID a3657d7f-5e0c-6061-e053-2995a90a0804

Route

EXTRACORPOREAL

Published

Effective Date 2020-04-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (375 mL)

Inactive Ingredients

Trolamine Carbomer Homopolymer, Unspecified Type Water

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-08

Description

keep it out of reach of children. Store between 0°C-43 C .

Medication Information

Warnings and Precautions

1.This product is for external use only.

2. Prohibited use for those allergic to alcohol. Prohibited use on the eyes.

3.Please keep it out of reach of children.Store between 0°C-43 C.

Indications and Usage

Take an appropriate amount of this product on the palm of your hand, rub your whole hands with it until it is dry, no washing required

Dosage and Administration

keep it out of reach of children. Store between 0°C-43 C .

Description

keep it out of reach of children. Store between 0°C-43 C .

Section 50565-1

keep out of children

Section 51727-6

Purified Water

Triethanolamine

Carbomer.

Section 51945-4

Section 55105-1

Disinfection

Sterilization

Section 55106-9

Ethanol

Structured Label Content

Indications and Usage (34067-9)

Take an appropriate amount of this product on the palm of your hand, rub your whole hands with it until it is dry, no washing required

Dosage and Administration (34068-7)

keep it out of reach of children. Store between 0°C-43 C .

Warnings and Precautions (34071-1)

1.This product is for external use only.

2. Prohibited use for those allergic to alcohol. Prohibited use on the eyes.

3.Please keep it out of reach of children.Store between 0°C-43 C.

Section 50565-1 (50565-1)

keep out of children

Section 51727-6 (51727-6)

Purified Water

Triethanolamine

Carbomer.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Disinfection

Sterilization

Section 55106-9 (55106-9)

Ethanol

Advanced Ingredient Data

[{"name": "TROLAMINE", "unii": "9O3K93S3TK", "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": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "375", "strengthDenominator": "500", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Take an appropriate amount of this product on the palm of your hand, rub your whole hands with it until it is dry, no washing required", "34068-7": "keep it out of reach of children. Store between 0°C-43 C .", "34071-1": "1.This product is for external use only. 2. Prohibited use for those allergic to alcohol. Prohibited use on the eyes. 3.Please keep it out of reach of children.Store between 0°C-43 C.", "50565-1": "keep out of children", "51727-6": "Purified Water Triethanolamine Carbomer.", "55105-1": "Disinfection Sterilization", "55106-9": "Ethanol"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:13.720436 · Updated: 2026-03-14T22:56:14.192854