Active Ingredient
Benzalkonium Chloride 0.13% w/w
America1 Hand Wipes
FDA Label NDC 82055-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by America1ppe Llc for the product America1 Hand Wipes (NDC 82055-013). 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, purpose, uses, warning, do not use, when using this product, stop use and ask a doctor, 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
Antibacterial
Uses
For handwashing to decrease bacteria on the skin
Warning
For external use only
Do Not Use
- In the eyes
- If you are allergic to any of the ingredients
When Using This Product
if eye contact occurs, rinse eyes thoroughly with water.
Stop Use And Ask A Doctor
if irritation and redness develops and persists for more than 72 hours
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Posion Control Center right away.
Directions
- Storage: Store at room temperature
- Dispensing: Remove seal band. Lift tab at front of lid. Pull out wipe and reseal lid. Close lid to retain moisture
- Use: Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
- Disposal: Dispose of used wipes in trash receptacle after use. Do not flush
Other Information
Production Date, Expiry Date and Lot Number on side
Inactive Ingredients
Benzoic Acid, C12-15 Pareth-12, Dehydroacetic acid, Fragrance, Glycerin, Phenoxyethanol, Purified Water, Tetrasodium Glutamate Diacetate
Principal Display Panel
NDC: 82055-013-90
America1 + ANTIBACTERIAL HAND WIPES
MADE IN USA
KILLS 99.99% OF GERMS*
* Kills 99.9% of germs that may cause illness| 90 wipes. 6.3 in X 7.1 in | Country of Origin: USA
Label (1)
* Please review the disclaimer below.
