ANTI-BACTERIAL HAND SANITIZING WIPES   - benzalkonium chloride liquid 
American Hygienics Corporation

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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Active Ingredient                                               Purpose

Benzalkonium Chloride 0.12 Percent..................Antiseptic

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

Do not use in the eyes.

Discontinue use if irritation and redness develop.  If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.  If swallowed, get medical help or contact Poison Control Center right away.

Open label, remove one wipe, and unfold.

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store below 95 degree Fahrenheit (35 degree Celsius)

May discolor certain fabrics or surfaces.

Inactive ingredients

Aloe barbadensis, Cetylpyridinium Chloride, Citric Acid, Disodium Cocoamphodiacetate, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Citrate, Tetrasodium EDTA, Water.


Manufactured in China by
ISO9001 accredited facility for
Premium Formulations LLC,
Newark, DE 19711, USA

Cleans and Refreshes without Soap, Water or Towel
Our thick, soft and strong have a mild antibacterial cleansing solution that kiss germs and bacteria while moisturizing your skin with ingredients like aloe vera.  The clean, crisp, invigorating scent is perfect for cleaning and refreshing.

ANTIBACTERIAL HAND WIPES ARE IDEAL FOR:

Home, Office, Car, Purse, Camping, Gym, Boating, Travelling, Anywhere a convenient, antibacterial clean up is required.



PF      25 Wipes

Premium Formulations

ANTI-BACTERIAL HAND SANITIZING WIPES

KILLS 99.9 percent OF GERMS


handsan25

Purpose: Antiseptic


ANTI-BACTERIAL HAND SANITIZING WIPES  
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15533-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM ) BENZALKONIUM CHLORIDE0.12 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE 
CITRIC ACID MONOHYDRATE 
PHENOXYETHANOL 
POLYSORBATE 20 
PROPYLENE GLYCOL 
SODIUM CITRATE 
PROPYLENE GLYCOL 
SODIUM CITRATE 
EDETATE SODIUM 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:15533-200-25250 g in 1 PACKAGENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333E03/23/201006/30/2011

Labeler - American Hygienics Corporation (545198454)
Registrant - American Hygienics Corporation (545198454)
Establishment
NameAddressID/FEIOperations
American Hygienics Corporation545198454manufacture

Revised: 06/2011 American Hygienics Corporation