Label: NYLOXIN STAGE 3 PAIN RELIEF- naja naja venom spray, metered

  • 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 350 mcg/mL

  • Purpose

    *
    According to the Homeopathic Pharmacopeia of the United States
    Analgesic*
  • INDICATIONS & USAGE

    Uses: Temporarily relieves pain associated with sore back, inflamed joints, migraines, painful menses, and general presistent pain

  • Warnings:

    -
    Side effects may include headahce, nausea, sore throat, allergic rhinitis and gastointestinal upset.
    -
    If symptoms persist or worsen, stop using this product and consult a physician.
    -
    When Using This Product: avoid contact with the eyes. If product gets into eyes, flush with water. Seek medical attention.
  • Directions For Use:

    • Break off protective tab.
    • Turn press lock so spray nozzle is visible in front.
    • Press down 4 x to prime the pump.
    • Spray 2 x directly into mouth or under tongue.
    • Use spray intially every 3-4 hours.
  • Other Information:

    • Do not use if tamper-proof seal is broken.
    • This product is NOT intended to treat disease, it can provide a temporary level of comfort, relief and a feeling of wellness.
    • This product has been determined to be safe and effective for moderate to severe (Stage 2) pain.
    • Clinical experience suggests Nyloxin may provide relief from other forms of pain.
  • SPL UNCLASSIFIED SECTION

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

    Citric Acid, Ethanol, Flavoring, Methylparaben, Sodium Citrate, Xylitol.

  • PRINCIPAL DISPLAY PANEL

    Package Label - Principal Display Panel – 1.0 oz Spray Label

    1.0 oz Spray Bottle Label

  • PRINCIPAL DISPLAY PANEL

    Package Label - Principal Display Panel – 1.0 oz Spray Carton

    1.0 oz Spray Bottle Carton

  • INGREDIENTS AND APPEARANCE
    NYLOXIN  STAGE 3 PAIN RELIEF
    naja naja venom spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47219-252
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM350 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    XYLITOL (UNII: VCQ006KQ1E)  
    2-(DIETHYLAMINO)ETHANOL (UNII: S6DL4M053U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47219-252-101 in 1 BOX
    130 mL in 1 BOTTLE, SPRAY
    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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