Active Ingredient(S)
Ethyl Alcohol 58%, Isopropyl Alcohol 12%, Alkyl Dimethyl Benzyl Ammonium Chloride 0.2%
Purpose: Antiseptic
Wonvia Antibacterial Hand Disinfectant Gel
FDA Label NDC 78876-710
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 Antibacterial Hand Disinfectant Gel (NDC 78876-710). 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
Antiseptic, Antibacterial Hand Disinfectant Gel
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- keep away from children
- on open skin wounds
- do not use in the cleaning of foodstuffs
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with plenty of 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.
Do not breathe directly.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. 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
- Use enough amount of solution to keep your hands wet. Rub hands together for 30 seconds.
- Keep away from children, food, and animal feed.
- Follow the instructions to avoid risks to human and environmental health.
Other Information
- Store between 15-30C (59-86F) in its original packaging upright in a cool dry place that does not receive direct sunlight.
- Avoid freezing and excessive heat above 40C (104F)
- Do not store more than 4 boxes in a row.
- Dispose of the container P501 in accordance with local regulations.
- use the unpacked product within 1 month.
- Shelf life (25+/2C) of the product is 2 years.
Inactive Ingredients
Softener 1.5%, Resolvent 28.19%, fragrance 0.1%, colouring 0.01%
resolvent is completed with 27.8%
proportion to 100%
Package Label - Principal Display Panel
1L NDC: 78876-710-10
5L NDC 78876-710-50
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