Label: NYLOXIN STAGE 3 PAIN RELIEF- naja naja venom gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated November 30, 2009

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  • Active Ingredients

    Asian Cobra venom 60 mcg/mL

  • 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 Pharmacopeia 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 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
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