Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3

Route

TOPICAL

Published

Effective Date 2024-03-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Benzalkonium (1.3 mg)

Inactive Ingredients

Water Glycerin Cocamidopropyl Betaine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-03-20

Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Use

To decrease bacteria on the skin.

Section 50566-9

Stop use and ask doctor if skin irritation develops.

Section 50570-1

Do not use in or near the eyes. In case of contact with eyes, flush thoroughly with water.

Warnings

For external use only.

Directions

Apply a small amount to palms, rub hands thoroughly until completely dry.

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not freeze.

Inactive Ingredients

Water, Glycerin, Cocamidopropyl Betaine.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Principal Display Panel – 225 Ml Bottle Label

NOVEX

HAND

SANITIZER

ALCOHOL FREE

7.6 FL OZ (225 mL)

Structured Label Content

Use

To decrease bacteria on the skin.

Section 50566-9 (50566-9)

Stop use and ask doctor if skin irritation develops.

Section 50570-1 (50570-1)

Do not use in or near the eyes. In case of contact with eyes, flush thoroughly with water.

Purpose

Antimicrobial

Warnings

For external use only.

Directions

Apply a small amount to palms, rub hands thoroughly until completely dry.

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Other Information

Do not freeze.

Inactive Ingredients

Water, Glycerin, Cocamidopropyl Betaine.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately.

Principal Display Panel – 225 Ml Bottle Label (Principal Display Panel – 225 mL Bottle Label)

NOVEX

HAND

SANITIZER

ALCOHOL FREE

7.6 FL OZ (225 mL)

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "To decrease bacteria on the skin.", "50566-9": "Stop use and ask doctor if skin irritation develops.", "50570-1": "Do not use in or near the eyes. In case of contact with eyes, flush thoroughly with water.", "Purpose": "Antimicrobial", "Warnings": "For external use only .", "Directions": "Apply a small amount to palms, rub hands thoroughly until completely dry.", "Active ingredient": "Benzalkonium Chloride 0.13%", "Other Information": "Do not freeze.", "Inactive Ingredients": "Water, Glycerin, Cocamidopropyl Betaine.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center immediately.", "Principal Display Panel – 225 mL Bottle Label": "NOVEX HAND SANITIZER ALCOHOL FREE 7.6 FL OZ (225 mL)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:53.963818 · Updated: 2026-03-14T23:02:42.365017