Label: EDX-502- iodine solution

  • NDC Code(s): 63927-4163-1, 63927-4163-2, 63927-4163-3, 63927-4163-4
  • Packager: ProActive Solutions USA, LLC

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 December 19, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • EDX-502

    EDX-502™ 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-502™. 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-502™. Allow teat to air dry. Do not wipe.
    Replace the solution if it becomes visibly dirty.


    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
    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-502

    iodine solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:63927-4163
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE0.5 kg  in 100 kg
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63927-4163-119.09 kg in 1 JUG
    2NDC:63927-4163-257.26 kg in 1 DRUM
    3NDC:63927-4163-3209.94 kg in 1 DRUM
    4NDC:63927-4163-41049.68 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/21/2010
    Labeler - ProActive Solutions USA, LLC (029368225)
    Registrant - ProActive Solutions USA, LLC (029368225)
    NameAddressID/FEIBusiness Operations
    ProActive Solutions USA, LLC029368225api manufacture, manufacture, pack, repack, label