Isseey Antibacterial Alcohol Wet Wipes
FDA Label NDC 80568-299
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Isseey for the product Isseey Antibacterial Alcohol Wet Wipes (NDC 80568-299). 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, directions, warnings, otc - keep out of reach of children, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
75% Ethyl Alcohol (12% v/v)
Benzalkonium Chloride (0.10% v/v)
Purpose
Antiseptic
Uses
• Apply on skin and surface to decrease bacteria and germs that may cause disease • recommended for repeated use.
Directions
• Remove top cover • pull up wipe corner from center of the roll and thread through hole in the cover • open center cap on cover to remove wipe • unfold wipe to disinfect skin and surface • let air dry your skin and surface • dispose wipe after using • when done using, close center cap carefully to prevent loss moisture • when apply on dirty surface, you must clean with another wipe before disinfecting.
Warnings
For external use only: hand, arm, leg and surface.
Flammable, keep away from fire, flame or heat.
When using this product • keep out of eye, In case of contact with eyes, flush thoroughly with water • avoid contact with broken or sensitive skin • do not use on face • do not put on your mouth.
Stop use ask a doctor if •irritation and redness develop • If the condition persists more than 72 hours consults with doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children • if put on mouth or swallowed, get medical help or contact a Poison Control Center right away.
Other Information
• Not recommended for infants use • for children under 6, must use under adult supervision • do not use as diaper wipe • rinse toys or food with clean water after disinfecting • do not use on unpainted wood • do not apply on dishes, glassware or utensils to disinfect
Storage and disposal • store wipe in original container in a cool, or dry place • keep container tightly closed • do not reuse or refill this container • do not flush • dispose wipes after using and put container in the trash.
Inactive Ingredients
Purified Water, Phenoxyethanol, Ethylhexylglycerin, Didecyldimonium Chloride, Propylene Glycol, Glycerin, Fragrance.
Packaging
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