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

Description

Ethyl Alcohol 80% v/v

Purpose

Antiseptic

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

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

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.

Drug Facts

Active Ingredient

Ethyl Alcohol 80% v/v

Other Information

• Store between 15-30C (59-86F)

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

Structured Label Content

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.

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.

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

Purpose

Antiseptic

Packaging

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.

Drug Facts

Active Ingredient (Active ingredient)

Ethyl Alcohol 80% v/v

Other Information (Other information)

• Store between 15-30C (59-86F)

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

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