FAST RESULTS GENITAL HERPES TREATMENT - benzalkonium chloride,allantoin liquid 
Merix Pharmaceutical Corp.

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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DRUGS FACTS

ACTIVE INGREDIENTS:

Benzalkonium chloride 0.13 %
Allantoin 0.5 %

USES:

For the relief of symptoms associated with genital herpes
First Aid to guard against secondary skin infection





WARNINGS:

Use only as directed. For external use only. Do not use if allergic to daisies.
Stop use and ask doctor if condition worsens or last more than 10 days.
Do not use on yeast infections.


KEEP OUT OF REACH OF CHILDREN:


Keep this and all drugs out of reach of children.

In case of accidental ingestion other then intended use, seek professional assistance
or call a poison control center.




DIRECTIONS:

Adults or adolescents 12 or older apply to clean dry area free of soap or cleanser residue.



Apply to area as need  3-4 times daily. Do no use cotton to apply.
Allow to dry.




Other Ingredients:

Purified water, Viracea ( a patented blend of Bensalkonium chloride and Echinacea)
Methylparaben, Propylparaben, Potassium sorbate.

Fast Results label
Fast Results label


FAST RESULTS GENITAL HERPES TREATMENT 
benzalkonium chloride,allantoin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63287-425
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mL  in 1 mL
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Methylparaben (UNII: A2I8C7HI9T)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Propylparaben (UNII: Z8IX2SC1OH)  
Echinacea purpurea flowering top (UNII: 2EMS3QFX65)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63287-425-251 in 1 BOX
125 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2006
Labeler - Merix Pharmaceutical Corp. (158385687)
Registrant - Topical Pharmaceutiocals Inc. (831530683)
Establishment
NameAddressID/FEIBusiness Operations
Topical Pharmaceutiocals Inc.831530683manufacture

Revised: 5/2012
Document Id: 9fa64ca3-1231-4922-9b52-295f1869746e
Set id: 5b2beccd-e83e-405a-95c7-ee4d86963655
Version: 1
Effective Time: 20120522
 
Merix Pharmaceutical Corp.