Label: NYLOXIN STAGE 2 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 3.5X

  • Purpose

    *
    According to the Homecopathic Pharmacopoeia of the United States
    Analgesic*
  • INDICATIONS & USAGE

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

  • Directions For Use:

    • Remove protective tab
    • Align arrow on top with opening
    • Press down on pump, spray 2X directly into the mouth
    • Use spray initially every 3-4 hours
    • Allow up to several days for drug to take maximum effect.
  • Other Information:

    • Do not use if tamper-proof is broken.
    • This product is NOT intended to treat disease
    • Clinical experience suggests Nyloxin may provide relief from other forms of pain.
  • Inactive Ingredients:

    Citric Acid, Ethanol, Methyl Paraben, Natural Flavoring, Sodium Citrate, Xylitol.

  • 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 the eyes, flush with water. Seek medical attention.
  • SPL UNCLASSIFIED SECTION

    • Pregnant or nursing women and children should not use this product unless advised by a physician.
  • SPL UNCLASSIFIED SECTION

    Mfd. for Nutra Pharma
    1537 NW 65th Ave.
    Plantation, FL 33313
    Question? 1-877-895-5647
    www.Nyloxin.com

  • PRINCIPAL DISPLAY PANEL

    Package Label - Principal Display Panel – 0.5 oz Spray Label

    0.5 oz Spray Bottle Label

  • INGREDIENTS AND APPEARANCE
    NYLOXIN  STAGE 2 PAIN RELIEF
    naja naja venom spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47219-202
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM.100 mg  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:47219-202-101 in 1 BOX
    115 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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