Hand Sanitizer

SPL v1

SPL

SPL Set ID a67127a7-d20e-8843-e053-2a95a90a27f9

Route

TOPICAL

Published

Effective Date 2020-05-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.0375 mL)

Inactive Ingredients

Glycerin Carbomer 940 Water Triethanolamine Caproyl Glutamate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-22

Description

Active ingredient Ethyl Alcohol 70%

Indications and Usage

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

Purpose

Purpose Antmicrobial

Dosage and Administration

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.

Warnings and Precautions

Warnings For external use only. Flammable. Keep away from heat or flame 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Medication Information

Warnings and Precautions

Warnings

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

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.

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

Indications and Usage

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

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.

Purpose

Purpose Antmicrobial

Dosage and Administration

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.

Description

Active ingredient Ethyl Alcohol 70%

Warnings

Warnings

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

Ask Doctor

Stop use and ask a doctor if irritation or rash occurs

Packaging Labels

Active Ingredient

Active ingredient Ethyl Alcohol 70%

Inactive Ingredients

Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

Keep Out of Reach of Children

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.

Structured Label Content

Purpose (PURPOSE)

Purpose Antmicrobial

Warnings (WARNINGS)

Warnings

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

Ask Doctor (ASK DOCTOR)

Stop use and ask a doctor if irritation or rash occurs

Packaging Labels (PACKAGING LABELS)

Active Ingredient (ACTIVE INGREDIENT)

Active ingredient Ethyl Alcohol 70%

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

Indications and Usage (INDICATIONS AND USAGE)

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

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.

Warnings and Precautions (WARNINGS AND PRECAUTIONS)

Warnings

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

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.

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

Dosage and Administration (DOSAGE AND ADMINISTRATION)

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.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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.

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.0375", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "0.002", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "0.2585", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "0.7", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TRIETHANOLAMINE CAPROYL GLUTAMATE", "unii": "0F2FO57253", "classCode": "IACT", "strengthNumerator": "0.002", "strengthDenominator": "1", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"PURPOSE": "Purpose Antmicrobial", "WARNINGS": "Warnings For external use only. Flammable. Keep away from heat or flame", "ASK DOCTOR": "Stop use and ask a doctor if irritation or rash occurs", "ACTIVE INGREDIENT": "Active ingredient Ethyl Alcohol 70%", "INACTIVE INGREDIENTS": "Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine", "INDICATIONS AND USAGE": "When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. 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.", "WARNINGS AND PRECAUTIONS": "Warnings For external use only. Flammable. Keep away from heat or flame 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "DOSAGE AND ADMINISTRATION": "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.", "KEEP OUT OF REACH OF CHILDREN": "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:41.611402 · Updated: 2026-03-14T22:56:56.523889