Label: PROVITA COMBAT- benzoic acid spray

  • NDC Code(s): 16371-101-01, 16371-101-02
  • 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

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

  • SPL UNCLASSIFIED SECTION

    Ingredients

    E124, E133, Ethanol, Organic Acids (Acetic and Benzoic),Polyvinylpyrrolidone, Tea tree Oil, Triacetin, Water

  • WARNINGS

    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.

  • SPL UNCLASSIFIED SECTION

    Tea tree oil is a natural antibacterial and antifungal essential oil. When contained in Combat, it forms a flexible, breathable film which seals out water, dirt and bacteria. For use on cattle, sheep and goats.

  • DOSAGE & ADMINISTRATION

    Wound: For skin lesions, cuts, scrapes and for minor surgical and processing interventions such as castration, ear notching and umbilical cord. Clean and dry area thoroughly before use. Shake container well and apply liberally. Allow 1-2 minutes for Combat film to form. Repeat daily as necessary.

  • DOSAGE & ADMINISTRATION

    Hoof: Clean area thoroughly, pare hoof if necessary. Shake container well and apply liberally. Allow 1-2 minutes for Combat film to form. Repeat daily as necessary for up to 1 week. If there is no improvement consult your veterinarian. Combat should be used as a part of a routine footcare programme. Use in conjunction with regular footbathing with Provita Hoofsure Endurance.

  • SPL UNCLASSIFIED SECTION

    Provita Eurotech Limited

    21 Bankmore Road, Omagh,

    Co. Tyrone, Northern Ireland, BT79 0EU Provita Animal Health LLC

    4500 140TH Avenue North,

    Suite 101, Clearwater, FL 33762

    Tel: + (1) 727 431 9511

    Email: info@provita-animalhealth.com www.provita-animalhealth.com

  • PRINCIPAL DISPLAY PANEL - 1 Litre Bottle Label

    Provita
    Animal Health Naturally

    ANTIBIOTIC
    FREE

    Combat

    Film-forming wound
    and hoof spray

    0.264 gal
    (1 Litre)

    100
    Applications

    PRINCIPAL DISPLAY PANEL - 1 Litre Bottle Label
  • INGREDIENTS AND APPEARANCE
    PROVITA   COMBAT
    benzoic acid spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:16371-101
    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
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16371-101-010.5 L in 1 BOTTLE, SPRAY
    2NDC:16371-101-021 L in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/02/2006
    Labeler - Provita Eurotech Ltd (238318232)
    Establishment
    NameAddressID/FEIBusiness Operations
    Provita Eurotech Ltd220688192MANUFACTURE, PACK, LABEL, ANALYSIS, API MANUFACTURE