Prefense Unscented Hand Sanitizer

SPL v7

SPL

SPL Set ID a59e9bbf-b60e-970a-e053-2a95a90aaa5e

Route

TOPICAL

Published

Effective Date 2020-05-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (120 mg)

Inactive Ingredients

Anhydrous Citric Acid Cocamidopropyl Betaine Water (3-chloropropyl)trimethoxysilane Isotonic Sodium Chloride Solution Methyl Alcohol Dimethyloctadecyl(3-(trimethoxysilyl)propyl)ammonium Chloride Acetic Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-05-15

Description

Hand and Skin Sanitizer

Medication Information

Warnings and Precautions

For external use only. Avoid contact with eyes. In case of eye contact, flush with water. Discontinue use if irritation or redness occurs.

Indications and Usage

Hand sanitizer to help reduce germs that potentially cause disease.

Dosage and Administration

Apply to dry hands, rub together, and let dry.

Description

Hand and Skin Sanitizer

Section 50565-1

Keep out of reach of children.

Section 51727-6

3-Chloropropyltrimethoxysilane, Acetic Acid, Anhydrous Citric Acid, Cocomidoprophyl betaine, Octadecyldimethyl (3-trimethoxysilylpropyl)ammonium chloride, Isotonic Sodium Chloride Solution, Water

Section 55105-1

Hand and Skin Sanitizer

Section 55106-9

Drug Facts

Active Ingredient

Benzalkonium Chloride ............0.12%

Package Label 1.5 Fl. Oz. Bottle Label

pre•fense _™

Hand Sanitizer

Unscented

protects

kills up to 99.99% of germs on contact

Moisturizes

silica based, alcohol-free

alcohol-free

won't dry out skin

120 Pumps

1.5 fl. oz.

Structured Label Content

Indications and Usage (34067-9)

Hand sanitizer to help reduce germs that potentially cause disease.

Dosage and Administration (34068-7)

Apply to dry hands, rub together, and let dry.

Warnings and Precautions (34071-1)

For external use only. Avoid contact with eyes. In case of eye contact, flush with water. Discontinue use if irritation or redness occurs.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

3-Chloropropyltrimethoxysilane, Acetic Acid, Anhydrous Citric Acid, Cocomidoprophyl betaine, Octadecyldimethyl (3-trimethoxysilylpropyl)ammonium chloride, Isotonic Sodium Chloride Solution, Water

Section 55105-1 (55105-1)

Hand and Skin Sanitizer

Section 55106-9 (55106-9)

Drug Facts

Active Ingredient

Benzalkonium Chloride ............0.12%

Package Label 1.5 Fl. Oz. Bottle Label (Package Label - 1.5 FL. OZ. BOTTLE LABEL)

pre•fense _™

Hand Sanitizer

Unscented

protects

kills up to 99.99% of germs on contact

Moisturizes

silica based, alcohol-free

alcohol-free

won't dry out skin

120 Pumps

1.5 fl. oz.

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "(3-CHLOROPROPYL)TRIMETHOXYSILANE", "unii": "T21BNL1S7F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOTONIC SODIUM CHLORIDE SOLUTION", "unii": "VR5Y7PDT5W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYL ALCOHOL", "unii": "Y4S76JWI15", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE", "unii": "IQ36O85WQ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETIC ACID", "unii": "Q40Q9N063P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "120", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Hand sanitizer to help reduce germs that potentially cause disease.", "34068-7": "Apply to dry hands, rub together, and let dry.", "34071-1": "For external use only. Avoid contact with eyes. In case of eye contact, flush with water. Discontinue use if irritation or redness occurs.", "50565-1": "Keep out of reach of children.", "51727-6": "3-Chloropropyltrimethoxysilane, Acetic Acid, Anhydrous Citric Acid, Cocomidoprophyl betaine, Octadecyldimethyl (3-trimethoxysilylpropyl)ammonium chloride, Isotonic Sodium Chloride Solution, Water", "55105-1": "Hand and Skin Sanitizer", "55106-9": "Drug Facts Active Ingredient Benzalkonium Chloride ............0.12%", "Package Label - 1.5 FL. OZ. BOTTLE LABEL": "pre•fense ™ Hand Sanitizer Unscented protects kills up to 99.99% of germs on contact Moisturizes silica based, alcohol-free alcohol-free won't dry out skin 120 Pumps 1.5 fl. oz."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:19.639370 · Updated: 2026-03-14T23:10:38.535907