51628-9999

51628-9999
SPL v5
SPL
SPL Set ID 2ba77bab-7d02-d7c7-e063-6294a90aae87
Route
TOPICAL
Published
Effective Date 2025-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Cocamidopropyl Pg-dimonium Chloride Phosphate Disodium Edta-copper Water Glycerin Sodium Benzoate Aloe Barbadensis Leaf .alpha.-tocopherol Acetate, D- Ethylhexylglycerin Phenoxyethanol Citric Acid Polysorbate 20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-15

Description

Benzalkonium Chloride 0.13%

Purpose

.Antibacterial


Medication Information

Purpose

.Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

decreases bacteria on skin

Section 50565-1

Keep out of reach of children. lf swallowedget medical help or contact a Poison ControlCenter right away.

Section 51945-4

Warning

For external use only.

Do not use if you are allergic to any of theingredients.

When using this product do not get into eyes.

f contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rashdevelops and continues for more than 72 hours

Directions

Adults and children 2 years and over.Apply to hands and allow to dry without wiping.

Children under 2 years. Ask a doctorbefore use.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water, Glycerin, Phenoxyethanol, SodiumBenzoate, Cocamidopropyl PG-DimoniumChloride Phosphate, Disodium EDTA, Polysorbate20, Citric Acid, Ethylhexylglycerin, AloeBarbadensis Leaf Juice, Tocopheryl Acetate.


Structured Label Content

Use (USE)

decreases bacteria on skin

Section 50565-1 (50565-1)

Keep out of reach of children. lf swallowedget medical help or contact a Poison ControlCenter right away.

Section 51945-4 (51945-4)

Purpose

.Antibacterial

Warning

For external use only.

Do not use if you are allergic to any of theingredients.

When using this product do not get into eyes.

f contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rashdevelops and continues for more than 72 hours

Directions

Adults and children 2 years and over.Apply to hands and allow to dry without wiping.

Children under 2 years. Ask a doctorbefore use.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Phenoxyethanol, SodiumBenzoate, Cocamidopropyl PG-DimoniumChloride Phosphate, Disodium EDTA, Polysorbate20, Citric Acid, Ethylhexylglycerin, AloeBarbadensis Leaf Juice, Tocopheryl Acetate.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)