Label: PHARMASEB- chlorhexidine gluconate, ketoconazole spray

  • NDC Code(s): 68898-118-04, 68898-118-08
  • Packager: Animal Pharmaceuticals
  • 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 November 21, 2022

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  • Drug Facts

  • Active Ingredients

    Chlorhexidine Gluconate, USP 2%
    Ketoconazole, USP 1%

  • Purpose

    Antibacterial
    Antifungal

  • Inactive Ingredients

    Water, Glycerin, Propylene Glycol, Polysorbate 20, Lactic Acid, PEG-75 Lanolin, Sodium Lactate, Aloe Barbadensis (Aloe Vera) Leaf Juice, Fragrance, Methylisothiazolinone.

  • Uses:

    A medicated spray with antimicrobial and antifungal activity designed for dogs, cats and horses with dermatological conditions responsive to chlorhexidine and ketoconazole.

  • Directions:

    Spray directly onto the affected area(s) up to 3 times daily, or as directed by veterinarian. Do not allow the animal to lick the treated areas until dry to prevent ingestion.

  • Precautions

    Avoid contact with eyes or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. Not for otic use. Wash hands after using.

  • Cautions

    If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

    Keep out of reach of children. In case of contact with eyes or mucous membranes, flush with copious amounts of water for 5-10 minutes. If irritation persists seek medical attention immediately.

  • SPL UNCLASSIFIED SECTION

    Antifungal and Antimicrobial Spray Formulation

    Cucumber Melon

    Formulated for Dogs, Cats & Horses

    At Animal Pharmaceuticals we strive to provide the best nutritional and topical treatments for your pet by going above and beyond.... and we don't stop there. We know that caring for your pet is just as important as caring for your own health, so we've developed and implemented systems that make things easier on you and convenient for your veterinarian.

    OUR ASSURANCE

    Animal Pharmaceuticals products are designed with our proprietary technology that helps retrieve and sustain the nutrients and healthful ingredients. Our proprietary formulation enhances the effects of functional ingredients and penetrates the skin and the effective areas to exert the corrective results.

    Additionally, and as always, you'll find that all our bottles and containers are made of recyclable plastic. Please help us protect the environment by recycling.

    ALL PRODUCTS ARE MADE IN THE U.S.A. AND 100% GUARANTEED

    To learn more about our products, visit:
    www.anmpharm.com

    MANUFACTURED FOR
    Animal Pharmaceuticals

    SOLD EXCLUSIVELY THROUGH LICENSED VETERINARIANS

    AX10034

    REV 0921

    MADE IN THE USA

  • Packaging

    Phseb-nw

  • INGREDIENTS AND APPEARANCE
    PHARMASEB 
    chlorhexidine gluconate, ketoconazole spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:68898-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g  in 100 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68898-118-04118 mL in 1 BOTTLE, SPRAY
    2NDC:68898-118-08237 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/13/2021
    Labeler - Animal Pharmaceuticals (166472444)
    Registrant - Stratford Care Usa, Inc. (036650469)
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Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

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Clinical Trials, PubMed, Biochemical Data Summary

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