Label: PROTOXIN- clostridium botulinum toxin type a gel

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 10, 2016

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  • ACTIVE INGREDIENT

    Clostridium botulinum Toxin Type A

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  • INACTIVE INGREDIENT

    Normal human serum albumin, Sodium chloride

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • WARNINGS

    Confirm the validity of the product label

    to make sure the sterilizatios is not damaged before using

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  • DOSAGE & ADMINISTRATION

    N/A

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  • INDICATIONS & USAGE

    N/A

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  • INGREDIENTS AND APPEARANCE
    PROTOXIN 
    clostridium botulinum toxin type a gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71066-0001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLOSTRIDIUM BOTULINUM (UNII: 0296055VE0) (CLOSTRIDIUM BOTULINUM - UNII:0296055VE0) CLOSTRIDIUM BOTULINUM 10 g  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71066-0001-1 10 mL in 1 VIAL; Type 0: Not a Combination Product 11/10/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 11/10/2016
    Labeler - PROTOX Inc. (689846300)
    Registrant - PROTOX Inc. (689846300)
    Establishment
    Name Address ID/FEI Business Operations
    PROTOX Inc. 689846300 manufacture(71066-0001)
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