Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 5a0aea16-b1ff-4fa1-a292-0f1447474593

Route

TOPICAL

Published

Effective Date 2025-07-15

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 2024-03-22

Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Use

To decrease bacteria on the skin.

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask doctor ifskin irritation develops.

Section 50570-1

Do not usein 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 and rub hands thoroughly until completely dry.

Questions?

www.x3clean.com

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not freeze.

Inactive Ingredients

Water, Glycerin, Cocamidopropyl Betaine.

Pricipal Display Panel 16 Fl Oz (473 Ml)

Clean

Hand Sanitizer

Foaming

Alcohol Free

Fragrance Free

Moisturizing Formula

Refill

16 fl oz. (473 mL)

Principal Display Panel – 59 Ml Bottle Label

clean

hand

sanitizer

spray

alcohol free

fragrance free

moisturizing

formula

2 fl oz (59 mL)

Structured Label Content

Use

To decrease bacteria on the skin.

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask doctor ifskin irritation develops.

Section 50570-1 (50570-1)

Do not usein 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 and rub hands thoroughly until completely dry.

Questions?

www.x3clean.com

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Other Information

Do not freeze.

Inactive Ingredients

Water, Glycerin, Cocamidopropyl Betaine.

Pricipal Display Panel 16 Fl Oz (473 Ml) (Pricipal Display Panel - 16 fl oz (473 mL))

Clean

Hand Sanitizer

Foaming

Alcohol Free

Fragrance Free

Moisturizing Formula

Refill

16 fl oz. (473 mL)

Principal Display Panel – 59 Ml Bottle Label (Principal Display Panel – 59 mL Bottle Label)

clean

hand

sanitizer

spray

alcohol free

fragrance free

moisturizing

formula

2 fl oz (59 mL)

Advanced Ingredient Data

[{"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": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "To decrease bacteria on the skin.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.", "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 and rub hands thoroughly until completely dry.", "Questions?": "www.x3clean.com", "Active ingredient": "Benzalkonium Chloride 0.13%", "Other Information": "Do not freeze.", "Inactive Ingredients": "Water, Glycerin, Cocamidopropyl Betaine.", "Pricipal Display Panel - 16 fl oz (473 mL)": "X3 Clean Hand Sanitizer Foaming Alcohol Free Fragrance Free Moisturizing Formula Refill 16 fl oz. (473 mL)", "Principal Display Panel – 59 mL Bottle Label": "X3 clean hand sanitizer spray alcohol free fragrance free moisturizing formula 2 fl oz (59 mL)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:36.899186 · Updated: 2026-03-14T23:09:29.869893