America1 Hand Wipes: Package Insert and Label Information

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.

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

  • 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
(click image for full-size original)
AMERICA1 HAND WIPES
benzalkonium chloride cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:82055-013
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID
DEHYDROACETIC ACID
C12-15 PARETH-12
GLYCERIN
PHENOXYETHANOL
WATER
TETRASODIUM GLUTAMATE DIACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82055-013-90 90 CLOTH in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/29/2021
Labeler — America1ppe LLC (117585490)
Registrant — America1ppe LLC (117585490)
Establishment
Name Address ID/FEI Operations
America1ppe LLC 117585490 manufacture (82055-013)

Revised: 06/2021 America1ppe LLC

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