Label: COBROXIN FOR CHRONIC PAIN- 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 3, 2009

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  • Active Ingredients

    *
    According to the Homeopathic Pharmacopeia of the United States
    Asian Cobra venom 4X *
  • Purpose

    Analgesic

  • INDICATIONS & USAGE

    Uses: Temporarily relieves pain associated with sore back, inflamed joints, migraines, dysmenorrhea (painful menses), and general chronic 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:

    • Remove protective wrapping.
    • Press down pump, spray twice directly into the mouth.
    • Use spray intially every 3-4 hours.
    • Allow several days for drug to take maximum effect.
  • Other Information:

    • Do not use if tamper-proof seal is broken.
    • This product is intended primarily to relieve chronic pain.
    • 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 Cobroxin 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, Methyl Paraben, Natural Flavoring, Purified Water

  • 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
    COBROXIN  FOR CHRONIC PAIN
    naja naja venom spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47219-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM.043 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:47219-102-521 in 1 BOX
    129 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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