PF FOAMING ANTI-BACTERIAL HAND SANITIZING

Dosage form: soap
Ingredients: BENZALKONIUM CHLORIDE 0.12mL in 100mL
Labeler: Premium Formulations LLC
NDC Code: 76323-004

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.

PF Foaming Anti-Bacterial Hand Sanitizing Soap

Active Ingredient                                             

Benzalkonium Chloride 0.12 %

Purpose
Antiseptic

Uses

  • For hand washing to decrease bacteria on the skin.

Warnings

For external use only.


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

Directions

  • Pump a small amount of foam onto palm of hand. Rub thoroughly over all surfaces of both hands. Wash hands clean.
  • Children under 6 should be supervised when using this product. Not recommended for infants.

Other information

Store below 95 degree Fahrenheit (35 degree Celsius)

May discolor certain fabrics or surfaces.

Inactive ingredients

Aloe barbadensis, Cocamidopropyl Betaine, Cocamide DEA, Fragrance (Parfum), Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Laureth Sulfate, Water (Aqua).


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



PF

Premium Formulations

Foaming

Anti-Bacterial Hand

Sanitizing Soap

Enriched With Aloe Vera

Kills 99.9%

Of Germs



250ml ( 8.5 fl oz)

PF FOAMING ANTI-BACTERIAL HAND SANITIZING 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76323-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM ) BENZALKONIUM CHLORIDE0.12 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
COCAMIDOPROPYL BETAINE 
COCO DIETHANOLAMIDE 
GLYCERIN 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
SODIUM LAURETH SULFATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:76323-004-00250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333E07/01/2011
Labeler - Premium Formulations LLC (831281097)
Registrant - American Hygienics Corporation (545198454)
Establishment
NameAddressID/FEIOperations
American Hygienics Corporation545198454manufacture

Revised: 07/2011
 
Premium Formulations LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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