Active Ingredient
Benzalkonium Chloride 0.13%
Antiseptic Wipes Swab
FDA Label NDC 58228-2011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prostat First Aid Llc for the product Antiseptic Wipes (NDC 58228-2011). 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, use(s), warnings, do not use, ask a doctor before use if, stop use and ask a doctor if, keep out of 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
Use(S)
• First aid to help prevent skin infection in minor cuts, scrapes, and burns.
Warnings
For External Use Only
Do Not Use
• As an antiseptic for more than 1 week
• In the eyes
Ask A Doctor Before Use If
you have deep or puncture wounds, animal bites, or serious burns.
Stop Use And Ask A Doctor If
• Irritation and redness develop
• Condition persists or gets worse
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
• Clean the affected area.
• May be covered with a sterile bandage.
• If bandaged, let dry first.
Other Information
• Store at room temperature 15°-30°C (59°-86°F).
• Avoid excessive heat.
• Tamper evident. Do not use if packet is torn or cut.
Inactive Ingredients
Water
Questions?
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Label
PS-2011
Ps-2011_bx_master (Ps 2011 Bx Master R231106 4)
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