Label: OVADINE- pvpi solution solution

  • NDC Code(s): 50378-009-50, 50378-009-51, 50378-009-54, 50378-009-55
  • Packager: Western Chemical Inc.
  • Category: OTC ANIMAL 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 July 21, 2020

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    DESCRIPTION

    DURING Water hardening of fish eggs
        · Immerse eggs in a solution of 50 PPM available Iodine for 30 minutes. To achieve a 50 PPM available
        iodine solution, mix 1 part Ovadine® to 200 parts clean water. This is a 1:200 dilution.
    AFTER Water hardening of fish eggs
        · Immerse eggs in a solution of 100 PPM available Iodine for 10 minutes. To achieve a 100 PPM
        available iodine solution, mix 1 part Ovadine® to 100 parts clean water. This is a 1:100 dilution.
        Rinse eggs with clean water after treatment.

    Ovadine® is non-toxic to green, fertilized and eyed eggs at the recommended application concentration. When in
    doubt, always seek the advice of a qualified fish health professional.

  • AMOUNT OF OVADINE PER UNIT OF WATER

    Desired Available Iodine Concentration

                            50 ppm                    100 ppm
                        (1:200 dilution)         (1:100 dilution)

    Per Liter
    of Water         5 ml Ovadine         10 ml Ovadine

    Per Gallon    18.9 ml Ovadine     37.8 ml Ovadine  
    of Water       0.64 oz Ovadine     1.28 oz Ovadine

  • Storage

    Store at room temperature between 59°F and 86°F (15°C and 30°C). Protect from direct sunlight.

  • Warning

    Do not use for disinfection of fish eggs intended for human or animal consumption. If product or
    diluted solution contaminates eyes, flush well with clean water. If irritation persists, contact a physician.

    Keep out of reach of children

  • PRINCIPAL DISPLAY PANEL

    Syndel USA Ovadine Label ver. 042622.jpg

    Syndel USA Ovadine Label ver. 042622.jpg

  • INGREDIENTS AND APPEARANCE
    OVADINE  
    pvpi solution solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:50378-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Iodine100 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R) 900 g  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50378-009-54208 L in 1 DRUM
    2NDC:50378-009-503.8 L in 1 BOTTLE, PLASTIC
    3NDC:50378-009-5119 L in 1 PAIL
    4NDC:50378-009-5515.2 L in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/09/2002
    Labeler - Western Chemical Inc. (085803500)
    Establishment
    NameAddressID/FEIBusiness Operations
    Western Chemical Inc.085803500manufacture, pack, label, analysis
    Establishment
    NameAddressID/FEIBusiness Operations
    BASF Corporation040776809api manufacture