Biopure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes Cloth
FDA Label NDC 78691-009
14 label sections · Submitted to the FDA by Quest Usa Corp. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quest Usa Corp. for the product Biopure Antibacterial Hand Wipes Benzalkonium Chloride 0.12% - 250 Wipes (NDC 78691-009). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Benzalkonium Chloride 0.12%
Purpose
Antibacterial
Uses
• Hand sanitizer to help reduce bacteria. • For use when soap and water are not available.
Warnings
For external use only.
Do Not Use
• in children less than 2 months old. • on open skin wounds.
When Using This Product
keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop Use And Ask A Doctor If
irritation or rash occurs. These may be signs of a serious condition.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Apply to hands, allow to air dry without wiping. • Children under 6 years of age should be supervised when using this product.
Other Information
• Store in a cool, dry place, between 15°-30° (59°-86°F). • Avoid freezing and excessive heat above 40°C (104°F).
Inactive Ingredients
Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water
Questions?
call 718-975-2586
Package Labeling:
Label2 (Label2)
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