Wipes Solutions Antibacterial Wet Wipes
FDA Label NDC 80310-036
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Supplyclean Industria De Produtos De Higiene S/a for the product Wipes Solutions Antibacterial Wet Wipes (NDC 80310-036). 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, otc - keep out of reach of children, directions, other information, 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% w/v
Purpose
Antibacterial
Uses
• hand wipes to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available
Warnings
Flammable, keep away from fire/flame
For external use only
Do not use
• in children less than 2 months of age
• on open skin wounds
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
• do not ingest
Stop use and ask a doctor if
• irritation and redness develop
• condition persists for more than 72 hours
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• remove the plastic cover and pull the tip of the first wipe in the center of the roll
• insert the tip of the scarf into the center opening of the cover from the bottom up
• replace the cap, pull the first wipe and the rest will come off automatically
• wipe hands thoroughly with product and allow to dry without wiping
• dispose of the wipe in the trash
• supervise children under 6 years of age when using this product to avoid swallowing
Other Information
• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above (104°F)
Inactive Ingredient
Inactive ingredients fragrance, propylene glycol
Otc - Questions
Questions? +1-844-805-8838
You may also report serious side effects to this phone number. Mon-Fri 9:00 AM-5:00 PM
Packaging
Image (80310036 18)
Image (80310036 36)
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