PF FOAMING ANTI-BACTERIAL HAND SANITIZING- benzalkonium chloride soap 
Premium Formulations 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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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).

Other Information


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)

HandSoap
PF FOAMING ANTI-BACTERIAL HAND SANITIZING 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76323-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE120 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76323-004-00250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/201107/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/01/201107/01/2011
Labeler - Premium Formulations LLC (831281097)
Registrant - American Hygienics Corporation (545198454)
Establishment
NameAddressID/FEIBusiness Operations
American Hygienics Corporation545198454manufacture(76323-004)

Revised: 11/2016
 
Premium Formulations LLC