Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID c8ed8510-b439-45f5-9bb7-952016aeac2c
Route
TOPICAL
Published
Effective Date 2016-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 g)
Inactive Ingredients
Chamomile Coco Monoethanolamide Cocamidopropyl Betaine Disodium Cocoamphodiacetate Polihexanide Water Achillea Millefolium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-10-27
Description

Benzakonium Chloride............Antiseptic

Purpose

Benzakonium Chloride............Antiseptic

Storage and Handling

Store at room temperature.

Medication Information

Warnings and Precautions

Warnings  For external use only.

Indications and Usage

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

Purpose

Benzakonium Chloride............Antiseptic

Storage and Handling

Store at room temperature.

Description

Benzakonium Chloride............Antiseptic

Uses

Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, includ-ing pressure sores, diabetic ulcers, cracked skin and lips. Topical antiseptic to help decrease the risk of skin infections.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

240 Ml Plpldp

473 Ml Plpldp

60 ml Plpldp

118 ml Plpldp

directions:

Wound cleansing for adults and children 2 years of age and older:

Spray the affected area to clean dirt and debris, use a small amount of the product and wipe it off with a sterile gauze.

For use as First Aid antiseptic for adults and children 2 years of age and older:

  • Clean the affected area
  • Spray a small amount of this product on the area 1 to 3 times daily or as needed
  • Wipe off excess with sterile gauze
  • Cover affected area with a sterile bandage if needed
  • When bandaged, let dry first

For children under 2 years of age: please, consult a doctor

inactive Ingredients:

chamomile, (matricaria recutita) extract, cocamide MEA, cocamidopropyl betaine, disodium cocamphodiacetate, polyhexanide, water, yarrow (achillea millefolium) extract

storage and Handling:

Store at room temperature.

Active Ingredient/purpose

Benzakonium Chloride............Antiseptic

Structured Label Content

Uses

Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, includ-ing pressure sores, diabetic ulcers, cracked skin and lips. Topical antiseptic to help decrease the risk of skin infections.

Indications and Usage (34067-9)

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

Warnings and Precautions (34071-1)

Warnings  For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

240 Ml Plpldp (240 mL PLPLDP)

473 Ml Plpldp (473 ml PLPLDP)

60 ml Plpldp (60 mL PLPLDP)

118 ml Plpldp (118 mL PLPLDP)

directions: (Directions:)

Wound cleansing for adults and children 2 years of age and older:

Spray the affected area to clean dirt and debris, use a small amount of the product and wipe it off with a sterile gauze.

For use as First Aid antiseptic for adults and children 2 years of age and older:

  • Clean the affected area
  • Spray a small amount of this product on the area 1 to 3 times daily or as needed
  • Wipe off excess with sterile gauze
  • Cover affected area with a sterile bandage if needed
  • When bandaged, let dry first

For children under 2 years of age: please, consult a doctor

inactive Ingredients: (Inactive ingredients:)

chamomile, (matricaria recutita) extract, cocamide MEA, cocamidopropyl betaine, disodium cocamphodiacetate, polyhexanide, water, yarrow (achillea millefolium) extract

storage and Handling: (Storage and handling:)

Store at room temperature.

Active Ingredient/purpose (Active Ingredient/Purpose)

Benzakonium Chloride............Antiseptic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:12.197552 · Updated: 2026-03-14T22:54:30.332332