AMERICA1 HAND WIPES- benzalkonium chloride cloth 
America1ppe LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antibacterial Hand Wipes

Active ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antibacterial

Uses

For handwashing to decrease bacteria on the skin

Warning

For external use only

Do not use

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

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

AMERICA1 HAND WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82055-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
C12-15 PARETH-12 (UNII: 131316X18L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82055-013-9090 in 1 POUCH; Type 0: Not a Combination Product06/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/29/2021
Labeler - America1ppe LLC (117585490)
Registrant - America1ppe LLC (117585490)
Establishment
NameAddressID/FEIBusiness Operations
America1ppe LLC117585490manufacture(82055-013)

Revised: 6/2021
Document Id: 02975350-0179-4e5e-8e3a-8b789de8fa17
Set id: bda34a73-4352-4484-a412-0d57346bb67d
Version: 1
Effective Time: 20210629
 
America1ppe LLC