75% hand sanitizer

SPL v4

SPL

SPL Set ID a3d95773-5f36-4f79-e053-2a95a90a131d

Route

topical

Published

Effective Date 2020-04-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (75 mL)

Inactive Ingredients

carbomer 940 trolamine water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-04-21

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 75% v/v. Purpose: Antiseptic

Medication Information

Warnings

For external use only. Flammable.

Keep away from heat or flame

Purpose

Antiseptic, Hand Sanitizer

Directions

Take 3mL of the product to moisten your hands and rub for 1 min until the liquid covers your hands, wait until dry, and no need to wash with water.

Other Information

Store in a cool, dry place (below 86F). Keep sealed.

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

Inactive Ingredients

Carbomer, Triethanolamine, Emollients, Essence and purified water

Description

Alcohol 75% v/v. Purpose: Antiseptic

Use

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

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Do Not Use

in children less than 2 months of age
on open skin wounds or if allergy to alcohol

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

60 mL NDC:75532-001-01

250 mL NDC:75532-001-02

500 mL NDC:75532-001-03

1000 mL NDC:75532-001-04

4000 mL NDC:75532-001-05

Structured Label Content

Warnings

For external use only. Flammable.

Keep away from heat or flame

Purpose

Antiseptic, Hand Sanitizer

Directions

Take 3mL of the product to moisten your hands and rub for 1 min until the liquid covers your hands, wait until dry, and no need to wash with water.

Other Information (Other information)

Store in a cool, dry place (below 86F). Keep sealed.

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

Inactive Ingredients (Inactive ingredients)

Carbomer, Triethanolamine, Emollients, Essence and purified water

Use

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

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 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Do Not Use (Do not use)

in children less than 2 months of age
on open skin wounds or if allergy to alcohol

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel (Package Label - Principal Display Panel)

60 mL NDC:75532-001-01

250 mL NDC:75532-001-02

500 mL NDC:75532-001-03

1000 mL NDC:75532-001-04

4000 mL NDC:75532-001-05

Advanced Ingredient Data

[{"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.", "50567-7": "When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "Purpose": "Antiseptic, Hand Sanitizer", "Warnings": "For external use only. Flammable. Keep away from heat or flame", "Directions": "Take 3mL of the product to moisten your hands and rub for 1 min until the liquid covers your hands, wait until dry, and no need to wash with water.", "Do not use": "in children less than 2 months of age on open skin wounds or if allergy to alcohol", "Other information": "Store in a cool, dry place (below 86F). Keep sealed. Supervise children under 6 years of age when using this product to avoid swallowing.", "Active Ingredient(s)": "Alcohol 75% v/v. Purpose: Antiseptic", "Inactive ingredients": "Carbomer, Triethanolamine, Emollients, Essence and purified water", "Package Label - Principal Display Panel": "60 mL NDC:75532-001-01 250 mL NDC:75532-001-02 500 mL NDC:75532-001-03 1000 mL NDC:75532-001-04 4000 mL NDC:75532-001-05"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:33.314960 · Updated: 2026-03-14T23:01:01.701433