NYLOXIN STAGE 3 PAIN RELIEF- naja naja venom gel 
RECEPTOPHARM INC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS

Active Ingredients

Asian Cobra venom 60 mcg/mL

Purpose

*
According to the Homeopathic Pharmacopeia of the United States
Analgesic*

Uses: Temporarily relieves joint pain associated with overuse and pain associated with arthritis.

Warnings:

-
For external use only
-
If symptoms persist or worsen, discontinue use and seek medical attention.
-
Avoid contact with eyes. If product gets into eyes, flush with water. Seek Medical attention.
-
Not for use on open wounds.

Directions For Use:

Other Information:

Inactive Ingredients:

Benzalkonium chloride, Ethanol, Methocel, Propylene glycol, Saline

Package Label - Principal Display Panel – 2.0 oz Gel Label

2.0 oz Gel Bottle Label

Package Label - Principal Display Panel – 2.0 oz Gel Carton

2.0 oz Gel Bottle Carton

NYLOXIN  STAGE 3 PAIN RELIEF
naja naja venom gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47219-253
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM60 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
2-(DIETHYLAMINO)ETHANOL (UNII: S6DL4M053U)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47219-253-201 in 1 BOX
160 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic08/25/2009
Labeler - RECEPTOPHARM INC (145377888)
Establishment
NameAddressID/FEIBusiness Operations
RECEPTOPHARM INC145377888ANALYSIS, MANUFACTURE, API MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
LIQUID PACKAGING RESOURCES018935165MANUFACTURE

Revised: 11/2009
Document Id: 8d5c7de0-ddbd-11de-9b36-0002a5d5c51b
Set id: 883f49a0-ddbd-11de-be01-0002a5d5c51b
Version: 1
Effective Time: 20091130
 
RECEPTOPHARM INC