43116-042

43116-042
SPL v1
SPL
SPL Set ID 371be299-5aaf-b9d7-e063-6294a90a87f5
Route
TOPICAL
Published
Effective Date 2025-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.15 U)
Inactive Ingredients
Phenoxyethanol Propylene Glycol Polysorbate 20 Octanediol Water Glycerin Aloe Barbadensis Leaf Lactic Acid, L- Chrysanthellum Indicum Top Citrus Aurantium Dulcis (orange) Fruit Powder Ethylhexylglycerin 1,2-hexanediol Hydroxyacetophenone Clove

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-09

Description

BENZALKONIUM CHLORIDE 0.15%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial





Description

BENZALKONIUM CHLORIDE 0.15%

Use

1 Gently cleanses external intimate areas (perianal & vulvar regions),

reduces bacteria on skin surfaces.

2.For personal hygiene after toileting or during menstrual care.



Stop Use

STOP USE and ask a doctor if:

Burning, swelling, or unusual discharge occurs



Warnings

FOR EXTERNAL USE ONLY. Disposable wipes, one time use only.



Directions

1.Wash hands before use

2.Unfold wipe without tearing

3.Gently wipe external intimate areas from front to back

4.rinse-free.



Do Not Use

1. If you are allergic to any ingredient in this product.

2. If packaging seal is compromised.

3. As a substitute for medical treatment.





When Using

Avoid contact with eyes, lips, and mouth. If contact occurs,

rinse thoroughly with water.



Active Ingredient

BENZALKONIUM CHLORIDE 0.15%



Other Information

Not have

Inactive Ingredients

Water, Glycerin, Propylene glycol, Polysorbate 20,

Phenoxyethanol, Octanediol, Aloe barbadensis Extract, Lactic acid,

Chrysanthellum Indicum Extract, Fragrance, Citrus Aurantium Dulcis

(Orange) Fruit extract, Ethylhexylglycerin, 1 ,2-Hexanediol,

Hydroxyacetophenone



Principal Display Panel

Keep Oot of Reach of Children

To avoid the risk of chocking and suffocation, keep wipes and

plastic bag away from babieschildren and pets.




Structured Label Content

Use

1 Gently cleanses external intimate areas (perianal & vulvar regions),

reduces bacteria on skin surfaces.

2.For personal hygiene after toileting or during menstrual care.



Purpose

Antimicrobial





Stop Use

STOP USE and ask a doctor if:

Burning, swelling, or unusual discharge occurs



Warnings

FOR EXTERNAL USE ONLY. Disposable wipes, one time use only.



Directions

1.Wash hands before use

2.Unfold wipe without tearing

3.Gently wipe external intimate areas from front to back

4.rinse-free.



Do Not Use (Do not use)

1. If you are allergic to any ingredient in this product.

2. If packaging seal is compromised.

3. As a substitute for medical treatment.





When Using

Avoid contact with eyes, lips, and mouth. If contact occurs,

rinse thoroughly with water.



Active Ingredient

BENZALKONIUM CHLORIDE 0.15%



Other Information (Other information)

Not have

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Propylene glycol, Polysorbate 20,

Phenoxyethanol, Octanediol, Aloe barbadensis Extract, Lactic acid,

Chrysanthellum Indicum Extract, Fragrance, Citrus Aurantium Dulcis

(Orange) Fruit extract, Ethylhexylglycerin, 1 ,2-Hexanediol,

Hydroxyacetophenone



Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

To avoid the risk of chocking and suffocation, keep wipes and

plastic bag away from babieschildren and pets.




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)