Label: EDX-1000- iodine solution

  • NDC Code(s): 63927-4160-1, 63927-4160-2, 63927-4160-3
  • Packager: ProActive Solutions USA, LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 20, 2023

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  • EDX-1000

    EDX-1000™ is a sanitizing iodine teat dip to aid in the prevention of the spread of
    mastitis causing organisms.

    Use instructions:

    Use full strength.

    Pre-Dipping: Just before milking, make sure the teats are clean and dry. Dip
    each teat in undiluted EDX-1000™. Allow 5-30 seconds of contact time. Dry with a
    single service towel and attach milker units.

    Post-Dipping: Immediately after removing inflations, dip each teat in undiluted                                                    EDX-1000™. Allow teat to air dry. Do not wipe.

    Replace the solution if it becomes visibly dirty.

    Caution:

    Hazard statement(s):
    May be harmful if swallowed. May cause eye irritation.
    Precautionary statement(s):
    Do not eat, drink or smoke while using this product. Wear protective clothing, and eye and
    face protection.
    Hazards not otherwise classified: None Known

    First Aid:

    General Advice: May cause eye irritation with corneal injury and result in impairment of
    vision.
    External: If irritation occurs, flush with plenty of cool, running water for at least 15 minutes
    while removing contaminated clothing and shoes. Wash clothing before reuse.
    Eyes: Immediately flush with plenty of cool, running water. Remove contact lenses; then
    continue flushing for at least 15 minutes, holding eyelids apart.
    Internal: Call a physician immediately. If swallowed, do not induce vomiting. Rinse mouth,
    then immediately drink one or two large glasses of water or milk. Never give anything by
    mouth to an unconscious person.
    Inhalation of vapors: Should not occur with proper use of this product.
    Most important symptoms/effects, acute and delayed: None known
    Immediate medical attention and special treatment needed, if any: None known

  • EDX-1000

    EDX-1000
  • INGREDIENTS AND APPEARANCE
    EDX-1000 
    iodine solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:63927-4160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE1 kg  in 100 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63927-4160-158.39 kg in 1 DRUM
    2NDC:63927-4160-2214.10 kg in 1 DRUM
    3NDC:63927-4160-31070.48 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/21/2010
    Labeler - ProActive Solutions USA, LLC (029368225)
    Registrant - ProActive Solutions USA, LLC (029368225)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProActive Solutions USA, LLC029368225api manufacture, manufacture, pack, repack, label, relabel