Active Ingredient(S)
Ethyl Alcohol 58%
Isopropyl Alcohol 12%
Alkyl Dimethyl Benzyl Ammonium Chloride 0.2%
Purpose: Antimicrobial
Wonvia Individually Wrapped Antibacterial Hand Wipes 70% Alcohol
FDA Label NDC 78876-713
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kaplan Distribution Llc for the product Wonvia Individually Wrapped Antibacterial Hand Wipes 70% Alcohol (NDC 78876-713). 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(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - 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
Antimicrobial, Hand Wipes
Use
Single-use hand wipes to help reduce bacteria on the skin. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
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 and/or redness develop. 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.
Otc - Stop Use
Stop use and ask a doctor if irritation and/or redness develop. These may be signs of a serious condition.
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
- Wet hands thoroughly with product and allow to dry.
- Discard wipes in a trash receptacle after use. Do not flush.
- Children under 6 years of age should be supervised when using this product.
Other Information
- Store between 15-30C (59-86F) at room temperature.
- Avoid freezing and excessive heat above 40C (104F)
- Flammable keep away from fire.
Inactive Ingredients
Softener 1.5%
Resolvent 28.19%
Fragrance 0.1%
Coloring 0.01%
Excipients and its amount (%): The resolvent is completed 27.8%
Proportion to 100%
Package Label - Principal Display Panel
Package Label: Principal Display Label (W1 Page 001)
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