Label: PROTOXIN- clostridium botulinum toxin type a gel

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

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Drug Label Information

Updated November 10, 2016

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  • ACTIVE INGREDIENT

    Clostridium botulinum Toxin Type A

  • INACTIVE INGREDIENT

    Normal human serum albumin, Sodium chloride

  • PURPOSE

    Stop a secretion of the neurotransmitter acetylcholine in a place to see nerves and muscles.
    Lessening the rigidity of the child with cerebral palsy using the qualities that lead to muscle paralysis.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS

    Confirm the validity of the product label

    to make sure the sterilizatios is not damaged before using

  • DOSAGE & ADMINISTRATION

    N/A

  • INDICATIONS & USAGE

    N/A

  • PRINCIPAL DISPLAY PANEL

    product label

  • INGREDIENTS AND APPEARANCE
    PROTOXIN 
    clostridium botulinum toxin type a gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71066-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOSTRIDIUM BOTULINUM (UNII: 0296055VE0) (CLOSTRIDIUM BOTULINUM - UNII:0296055VE0) CLOSTRIDIUM BOTULINUM10 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71066-0001-110 mL in 1 VIAL; Type 0: Not a Combination Product11/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/10/2016
    Labeler - PROTOX Inc. (689846300)
    Registrant - PROTOX Inc. (689846300)
    Establishment
    NameAddressID/FEIBusiness Operations
    PROTOX Inc.689846300manufacture(71066-0001)
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