Active Ingredient
Benzalkonium Chloride 0.13% w/v
Benzalkonium Chloride Cloth
FDA Label NDC 69396-186
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Benzalkonium Chloride (NDC 69396-186). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, warnings, use, stop use and ask doctor, do not use, ask doctor before use, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antiseptic
Warnings
For external use only:
Do Not insert into the Vagina
Use
Towelette to help prevent the risk of skin infection.
Stop Use And Ask Doctor
Stope Use and Ask Doctor if:
- If conidition persists or gets worse.
Stop use and ask doctor if the condition persists or gets worse.
Do Not Use
Do Not Use in the eyes or apply over large areas of the body.
Do Not use longer than 1 week unless directed by a doctor.
Do Not Reuse
Ask Doctor Before Use
Ask Doctor before use if you have deep or puncture wounds, animal bites, or serious burns.
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Tear open packet
- Unfold and clean the affected area
- discard after single use
Inactive Ingredients
Sodium Bicarbonate, water
Other Information
Store at room temperature 15°-30°F (59°-86°F)
Sterile unless pouch is open or damaged
Distributed by
Trifecta Pharmaceuticals USA
101 NE Third Aveue, Suite 1500
Fort Lauderdale, FL 33301
www.trifecta-pharma.com
Questions
Questions or Comments
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