NYLOXIN STAGE 2 PAIN RELIEF (NAJA NAJA VENOM) GEL [RECEPTOPHARM INC]

NYLOXIN STAGE 2 PAIN RELIEF (NAJA NAJA VENOM) GEL [RECEPTOPHARM INC]
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NDC 47219-204-20
Set ID b3eaf020-d9ff-11de-a9cf-0002a5d5c51b
Category HUMAN OTC DRUG LABEL
Packager RECEPTOPHARM INC
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredients

    Asian Cobra venom 5X

  • Purpose

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

  • INDICATIONS & USAGE

    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:

    • Remove protective wrapping.
    • Liberally apply gel to the affected area and rub into joints.
    • Use 3-4 times per day for the first week. Use as needed thereafter to relieve discomfort.
    • Allow several days for drug to take maximum effect.
  • Other Information:

    • Do not use if container seal is broken prior to opening.
    • This product is intended for use in cases of recurring joint pain.
    • This product is NOT intended to treat disease. It provides a temporary level of comfort, relief and a feeling of wellness.
    • This product has been determined to be safe and effective for mild to moderate (Stage 2) chronic pain, as indicated by the Homeopathic Pharmacopea of the United States.
  • SPL UNCLASSIFIED SECTION

    • Pregnant or nursing women and children should not use this product unless advised by a physician
  • Inactive Ingredients:

    Benzalkonium chloride, Ethanol, Methocel, Propylene glycol, Saline

  • PRINCIPAL DISPLAY PANEL

    Package Label - Principal Display Panel – 2.0 oz Gel Label

    2.0 oz Gel Bottle Label

  • PRINCIPAL DISPLAY PANEL

    Package Label - Principal Display Panel – 2.0 oz Gel Carton

    2.0 oz Gel Bottle Carton

  • INGREDIENTS AND APPEARANCE
    NYLOXIN  STAGE 2 PAIN RELIEF
    naja naja venom gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47219-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM.020 mg  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:47219-204-201 in 1 BOX
    130 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

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