hand sanitizer gel

SPL v4

SPL

SPL Set ID a4748c49-6de6-75f5-e053-2995a90ad3aa

Route

topical

Published

Effective Date 2020-04-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (75 mL)

Inactive Ingredients

carbomer homopolymer, unspecified type trolamine water dimethylamine glycerin

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-04-29

Description

Alcohol 75% v/v. Purpose: Antiseptic

Medication Information

Warnings and Precautions

For external use only

Flammable, keep away from fire or flame

Do not apply around eyes.

Active Ingredient

Alcohol 75% v/v. Purpose: Antiseptic

Indications and Usage

Help decrease bacteria on skin.

Recommended for repeated use

Dosage and Administration

Pump as needed into your palms & thoroughly spread on both hands.

Description

Alcohol 75% v/v. Purpose: Antiseptic

Section 50565-1

Keep our of reach of Children. Children must be supervised in use of this product.

Section 50566-9

Stop use and ask a doctor if irritation or redness develops & condition persists for more than 72 hours.

Section 50567-7

When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

Section 51727-6

Water, Glycerin, Triethanolamine, Carbomer, Dimethylamino

Section 55105-1

Antiseptic, Hand Sanitizer

Section 60561-8

Do not store above 110F

Package Label Principal Display Panel

60 mL NDC: 74235-001-01

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Flammable, keep away from fire or flame

Do not apply around eyes.

Active Ingredient (55106-9)

Alcohol 75% v/v. Purpose: Antiseptic

Indications and Usage (34067-9)

Help decrease bacteria on skin.

Recommended for repeated use

Dosage and Administration (34068-7)

Pump as needed into your palms & thoroughly spread on both hands.

Section 50565-1 (50565-1)

Keep our of reach of Children. Children must be supervised in use of this product.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops & condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

Section 51727-6 (51727-6)

Water, Glycerin, Triethanolamine, Carbomer, Dimethylamino

Section 55105-1 (55105-1)

Antiseptic, Hand Sanitizer

Section 60561-8 (60561-8)

Do not store above 110F

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

60 mL NDC: 74235-001-01

Advanced Ingredient Data

[{"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "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"}, {"name": "DIMETHYLAMINE", "unii": "ARQ8157E0Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Help decrease bacteria on skin. Recommended for repeated use", "34068-7": "Pump as needed into your palms & thoroughly spread on both hands.", "34071-1": "For external use only Flammable, keep away from fire or flame Do not apply around eyes.", "50565-1": "Keep our of reach of Children. Children must be supervised in use of this product.", "50566-9": "Stop use and ask a doctor if irritation or redness develops & condition persists for more than 72 hours.", "50567-7": "When using this product, avoid contact with eyes. In case of contact, flush eyes with water.", "51727-6": "Water, Glycerin, Triethanolamine, Carbomer, Dimethylamino", "55105-1": "Antiseptic, Hand Sanitizer", "55106-9": "Alcohol 75% v/v. Purpose: Antiseptic", "60561-8": "Do not store above 110F", "Package Label - Principal Display Panel": "60 mL NDC: 74235-001-01"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:58:18.854282 · Updated: 2026-03-14T22:57:47.608901