Label: PROVITA EQUIBAND- benzoic acid spray

  • NDC Code(s): 16371-105-01, 16371-105-02, 16371-105-03
  • Packager: Provita Eurotech Ltd
  • 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 December 17, 2018

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  • DESCRIPTION

    Ingredients

    E110, Ethanol, Organic Acids (Acetic and Benzoic), Polyvinylpyrrolidone, Tea-tree Oil, Triacetin, Water

  • SPL UNCLASSIFIED SECTION

    Tea-tree oil is a natural essential oil. When incorporated into Equiband it forms a flexible, breathable film which seals out water, dirt and bacteria. This spray plaster covers the affected area like a second skin and allows natural healing.

  • PRECAUTIONS

    Danger: Flammable liquid and vapour. Harmful if swallowed. Keep away from heat/ sparks/open flames/hotsurfaces — No smoking. Do not breathe dust / fume / gas / mist / vapours / spray. Wear protective gloves/ protective clothing/eye protection/face protection. IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do, continue rinsing. If symptoms persist, immediately call a POISON CENTER or doctor/physician. In case of fire: Use water, carbon dioxide (CO2), foam, dry powder for extinction. Store in a well-ventilated place. Keep cool. Keep out of reach of children.

    For animal use only.

  • DOSAGE & ADMINISTRATION

    Directions for Use

    For use topically on hooves and all skin types (except face). Clean and dry the area carefully before use. Spray an even coating and allow 1-2 minutes for the film to form.

    For hoof areas, ensure that the film is formed before returning the hoof to the ground. Where necessary, repeat application every 2 days for up to 10 days.

  • PRINCIPAL DISPLAY PANEL - 500 ml Bottle Label

    Provita

    Equiband

    A spray plaster for
    horses containing
    tea-tree oil.

    500ml

    PRINCIPAL DISPLAY PANEL - 500 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    PROVITA EQUIBAND 
    benzoic acid spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:16371-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoic acid (UNII: 8SKN0B0MIM) (Benzoic acid - UNII:8SKN0B0MIM) Benzoic acid74 g  in 1 L
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16371-105-010.5 L in 1 BOTTLE, SPRAY
    2NDC:16371-105-021 L in 1 BOTTLE, SPRAY
    3NDC:16371-105-030.25 L in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/01/2012
    Labeler - Provita Eurotech Ltd (238318232)
    Establishment
    NameAddressID/FEIBusiness Operations
    Provita Eurotech Ltd220688192MANUFACTURE, PACK, LABEL, ANALYSIS, API MANUFACTURE