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.

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 55106-9

Alcohol 75% v/v. Purpose: Antiseptic

Section 60561-8

Do not store above 110F

Package Label Principal Display Panel

60 mL NDC: 74235-001-01

Structured Label Content

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.

Warnings and Precautions (34071-1)

For external use only

Flammable, keep away from fire or flame

Do not apply around eyes.

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 55106-9 (55106-9)

Alcohol 75% v/v. Purpose: Antiseptic

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

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