Label: API BETTAFIX- melaleuca liquid

  • NDC Code(s): 17163-093-02
  • Packager: MARS FISHCARE NORTH AMERICA, INC.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 10, 2024

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  • DESCRIPTION

    BENEFITS:

    A safe, all natural way to treat Bettas for bacterial infections.

    Contains the healing power of Melaleuca (Tea Tree), a botanical extract, to treat open wounds and tissue damage by handling and netting.

  • INDICATIONS & USAGE

    WHEN TO USE:

    Use whenever Bettas exhibit signs of bacterial disease, such as frayed or torn fins, red ulcers or slimy patches.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR USE:

    Add 1/8 tsp (0.6mL) per quart (946mL) or 1/4 tsp. (1.25mL) per 1/2 U.S. gallon (1.9L) of water.

    For larger bowls or aquariums, add 1/2 teaspoonful (2.5 ml) per 1 U.S. gallon (3.8 L) of water.

    Repeat dose daily for up to 7 days, and then make a water change.

    Treatment may be repeated, if necessary. Store below 100.4ºF (38ºC).

    For tropical fish use only.

  • ACTIVE INGREDIENT

    Contains: Melaleuca oil (cajeput oil 0.2%)

  • USER SAFETY WARNINGS

    !

    DANGER

    Contains Melaleuca oil (cajeput oil 0.2%)

    EC no. 287-316-4  CAS n. 8008-98-8

    Harmful if swallowed.

    Causes serious eye irritation.

    Causes skin irritation.

    IF SWALLOWED: Call a Poison Center or Physician.

    For animal treatment only. Not for human consumption or for treatment of fish intended for human consumption. Keep out of reach of children.

    WARNING: This product can expose you to chemicals including beta-Myrcene, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

    Store below 100°F (38ºC).

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    API BETTAFIX 
    melaleuca liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17163-093
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAJUPUT OIL (UNII: J3TO6BUQ37) (CAJUPUT OIL - UNII:J3TO6BUQ37) CAJUPUT OIL0.2 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17163-093-0250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2005
    Labeler - MARS FISHCARE NORTH AMERICA, INC. (049630700)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARS FISHCARE NORTH AMERICA, INC.049630700manufacture, api manufacture