The Fab Korea Co., Ltd. - Purus Hand Sanitizer Gel 500ml

SPL v2

SPL

SPL Set ID a55c212a-b13e-3e6d-e053-2995a90aae8e

Route

TOPICAL

Published

Effective Date 2017-08-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (350 mL)

Inactive Ingredients

Water Glycerin Dipropylene Glycol Carbomer Homopolymer, Unspecified Type Isopropyl Myristate Trolamine Hyaluronate Sodium Green Tea Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-04

Description

Alcohol

Medication Information

Warnings and Precautions

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

Do not use

in children less than 2 months of age
on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Indications and Usage

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

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

Dosage and Administration

for external use only

Description

Alcohol

Section 50565-1

keep out of reach of the children

Section 51727-6

water, glycerin, dipropylene glycol, carbomer, isopropyl myristate, triethanolamine, sodium hyaluronate, camellia sinensis leaf extract

Section 51945-4

Section 55105-1

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.

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

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

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

Do not use

in children less than 2 months of age
on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

water, glycerin, dipropylene glycol, carbomer, isopropyl myristate, triethanolamine, sodium hyaluronate, camellia sinensis leaf extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 55106-9 (55106-9)

Alcohol

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPROPYLENE GLYCOL", "unii": "E107L85C40", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYALURONATE SODIUM", "unii": "YSE9PPT4TH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GREEN TEA LEAF", "unii": "W2ZU1RY8B0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "350", "strengthDenominator": "500", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.", "34068-7": "for external use only", "34071-1": "For external use only. Flammable. Keep away from heat or flame. Do not use in children less than 2 months of age on open skin wounds When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50565-1": "keep out of reach of the children", "51727-6": "water, glycerin, dipropylene glycol, carbomer, isopropyl myristate, triethanolamine, sodium hyaluronate, camellia sinensis leaf extract", "55105-1": "Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "55106-9": "Alcohol"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:48.130705 · Updated: 2026-03-14T22:57:04.097940