pure usa the original

SPL v1

SPL

SPL Set ID 1f935afc-6a99-480a-ae5f-e0a9c71b9842

Route

topical

Published

Effective Date 2020-10-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (80 L)

Inactive Ingredients

glycerin hydrogen peroxide water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-09-25

Purpose

Antiseptic

Description

Ethyl Alcohol 80% v/v

Medication Information

Warnings and Precautions

Warnings For external use only. Flammable. Keep away from flame 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 eyes thoroughly with water

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

Indications and Usage

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

Purpose

Antiseptic

Directions

• 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.

Other Information

• Store between 15-30C (59-86F)

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

Description

Ethyl Alcohol 80% v/v

Section 42229-5

Manufactured By:

Pure USA, LLC

Richand Hills, TX 76118

MADE IN USA

833-4-MY-PURE

Section 50565-1

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

Section 51727-6

Inactive ingredients glycerin, hydrogen peroxide, purified water USP, fragrance

Packaging

Drug Facts

Active Ingredient

Ethyl Alcohol 80% v/v

Structured Label Content

Warnings and Precautions (34071-1)

Warnings For external use only. Flammable. Keep away from flame 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 eyes thoroughly with water

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

Indications and Usage (34067-9)

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

Purpose

Antiseptic

Directions

• 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.

Other Information (Other information)

• Store between 15-30C (59-86F)

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

Section 42229-5 (42229-5)

Manufactured By:

Pure USA, LLC

Richand Hills, TX 76118

MADE IN USA

833-4-MY-PURE

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients glycerin, hydrogen peroxide, purified water USP, fragrance

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Ethyl Alcohol 80% v/v

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "100", "strengthNumeratorUnit": "L", "strengthDenominatorUnit": "L"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "34071-1": "Warnings For external use only. Flammable. Keep away from flame 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 eyes thoroughly with water Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.", "42229-5": "Manufactured By: Pure USA, LLC Richand Hills, TX 76118 MADE IN USA 833-4-MY-PURE", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive ingredients glycerin, hydrogen peroxide, purified water USP, fragrance", "Purpose": "Antiseptic", "Directions": "• 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.", "Active ingredient": "Ethyl Alcohol 80% v/v", "Other information": "• Store between 15-30C (59-86F) • Avoid freezing and excessive heat above 40C (104F)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:51.535689 · Updated: 2026-03-14T22:58:38.353182