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Name:Anti-bacterial Hand Sanitizing Wipes
Manufacturer:American Hygienics Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Anti-Bacterial Hand Sanitizing Wipes

ANTI-BACTERIAL HAND SANITIZING WIPES  - benzalkonium chloride swab 
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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Anti-Bacterial Hand Sanitizing Wipes

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


ANTI-BACTERIAL HAND SANITIZING WIPES 
benzalkonium chloride swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15533-200
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM ) BENZALKONIUM CHLORIDE 0.12   in 100 
Inactive Ingredients
Ingredient Name Strength
CETYLPYRIDINIUM CHLORIDE  
CITRIC ACID MONOHYDRATE  
PHENOXYETHANOL  
POLYSORBATE 20  
PROPYLENE GLYCOL  
SODIUM CITRATE  
PROPYLENE GLYCOL  
SODIUM CITRATE  
EDETATE SODIUM  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15533-200-25 25 SWAB ( SWAB) in 1 PACKAGE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 03/23/2010

Labeler - American Hygienics Corporation (545198454)
Registrant - American Hygienics Corporation (545198454)
Establishment
Name Address ID/FEI Operations
American Hygienics Corporation 545198454 manufacture

Revised: 03/2010 American Hygienics Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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