NYLOXIN STAGE 3 PAIN RELIEF (NAJA NAJA VENOM) SPRAY, METERED [RECEPTOPHARM INC]

NYLOXIN STAGE 3 PAIN RELIEF (NAJA NAJA VENOM) SPRAY, METERED [RECEPTOPHARM INC]
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NDC 47219-250-10
Set ID 33c96620-d90e-11de-8f2e-0002a5d5c51b
Category HUMAN OTC DRUG LABEL
Packager RECEPTOPHARM INC
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredients

    Asian Cobra venom 140 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 headache, nausea, sore throat, allergic rhinitis and gastrointestinal 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:47219-250
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM140 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:47219-250-101 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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