Label: FORTICEPT MAXI-WASH PLUS- chlorhexidine gluconate and ketokonazole liquid

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 20, 2022

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  • Active Ingredients:

    Chlorhexidine Gluconate.......2%

    Ketokonazole.......1%

  • Inactive ingredients:

    Aloe Vera Leaf, Calendula Officinalis Extract, Caprylyl Glycol, Dimethyl Sulfoxide, Glycerin, Lactic Acid, Phenoxyethanol, Polihexanide, Polysorbate 20, Propylene Glycol, Water

  • Indications:

    For use on dogs, cats, and horses with bacterial or fungal skin infections that are responsive to chlorhexidine or ketoconazole. Topical antiseptic to help decrease the risk of infection.

  • Warnings:

    For external use only / Not for human use
    Keep out of reach of children
    When using this product - avoid eye contact or ingestion
    Stop use and ask a veterinarian if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

  • Directions:

    Use 1 to 3 times per day or as directed by your veterinarian. Spray directly on the affected area of the skin. Do not allow the animal to lick the treated area until it is dry to prevent ingestion.

  • Storage:

    Do not store below 32°F/0°C or above 95°F/35°C for extended periods of time. In case of a spill, flood with water.

  • First Aid:

    Eye contact: In case of contact, immediately flush eyes with cool running water.
    Skin contact: Wash the skin with water and soap. Wash clothing before reuse.
    Ingestion: If large quantities of this material are swallowed, contact poison control center immediately

  • 8 fl. oz. Label

    8 fl. oz. Label

  • INGREDIENTS AND APPEARANCE
    FORTICEPT MAXI-WASH PLUS 
    chlorhexidine gluconate and ketokonazole liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:72127-0804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 g  in 1000 g
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE10 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72127-0804-1237 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/20/2022
    Labeler - Lidan, Inc. (014456716)
    Registrant - Lidan, Inc. (014456716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture, api manufacture, analysis, pack
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