b3cbe54a-0c77-0b6c-e053-2a95a90aca27

SPL v1

SPL

SPL Set ID b3cbe54a-0c77-0b6c-e053-2a95a90aca27

Route

topical

Published

Effective Date 2020-11-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (70 mL)

Inactive Ingredients

carbomer homopolymer, unspecified type glycerin water trolamine benzalkonium chloride

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph not final active Since 2020-11-16

Purpose

Antiseptic

Description

Alcohol 70% v/v

Medication Information

Warnings

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

Purpose

Antiseptic

Directions

*Put enough product in your palm to cover hands and rub hands together until dry.

*Children under 6 years of age should be supervised when using this product.

Other Information

*Store below 110°F (43°C)

*May discolor certain fabric

Inactive Ingredients

Deionized water, glycerin carbomer, triethanolamine, benzalkonium chloride

Description

Alcohol 70% v/v

Use(s)

Hand sanitizer to help reduce bacteria on the skin that potentially can cause disease. For use when soap 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 appears and lasts.

Section 50567-7

When using this product: Keep out of eyes, ears,a nd mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1

Do Not Use

*On children less then 2 months of age

*On open skin wounds

Active Ingredient(s)

Alcohol 70% v/v

Package Label Principal Display Panel

Structured Label Content

Warnings

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

Purpose

Antiseptic

Directions

*Put enough product in your palm to cover hands and rub hands together until dry.

*Children under 6 years of age should be supervised when using this product.

Other Information (Other information)

*Store below 110°F (43°C)

*May discolor certain fabric

Inactive Ingredients (Inactive ingredients)

Deionized water, glycerin carbomer, triethanolamine, benzalkonium chloride

Use(s)

Hand sanitizer to help reduce bacteria on the skin that potentially can cause disease. For use when soap 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 appears and lasts.

Section 50567-7 (50567-7)

When using this product: Keep out of eyes, ears,a nd mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1 (50570-1)

Do Not Use

*On children less then 2 months of age

*On open skin wounds

Active Ingredient(s)

Alcohol 70% v/v

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

Advanced Ingredient Data

[{"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "Hand sanitizer to help reduce bacteria on the skin that potentially can cause disease. For use when soap 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: I f irritation or rash appears and lasts.", "50567-7": "When using this product: Keep out of eyes, ears,a nd mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "50570-1": "Do Not Use *On children less then 2 months of age *On open skin wounds", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from heat or flame.", "Directions": "*Put enough product in your palm to cover hands and rub hands together until dry. *Children under 6 years of age should be supervised when using this product.", "Other information": "*Store below 110°F (43°C) *May discolor certain fabric", "Active Ingredient(s)": "Alcohol 70% v/v", "Inactive ingredients": "Deionized water, glycerin carbomer, triethanolamine, benzalkonium chloride"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:03.248306 · Updated: 2026-03-14T22:58:52.562418