Label: 0.1% KETOCONAZOLE, 0.15% SALICYLIC ACID- ear rinse solution, gel forming / drops

  • NDC Code(s): 21091-269-01
  • Packager: Sergeant's Pet Care Products LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated April 19, 2024

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  • PURPOSE

    PetArmor® Ear Rinse

    For Dogs and Cats

    Aid in drying or cleansing

    Gently cleans away dirt and was

    PetArmor® Ear Rinse can be used for gentle flushing and cleansing of skin and ears in conditions where an antibacterial and antifungal formulation is indicated. It also lowers the pH in the ear to inhibit bacterial growth.

  • ACTIVE INGREDIENTS:

    0.1% Ketoconazole, 0.15% Salicylic Acid

  • INACTIVE INGREDIENTS:

    Purified Water, Propylene Glycol, Glycerin, Polysorbate 20, Lactic Acid, Ale Barbadensis (Aloe Vera) Leaf Juice, Methylisothiazolinone, Nonoxynol-9, Sodium Hydroxide

  • Directions for Use:

    SHAKE WELL. For use as an ear flush: apply to the ear canal and gently, but firmly, massage the base of the ear. Use a cotton ball to remove excess solution. Repeat as necessary or as directed by your veterinarian. Close cap tightly for storage.

  • CAUTION:

    For topical use only. Do not use on severely irritated skin – contact your veterinarian. If skin irritation develops or increases or you see no
    improvement, stop use and call your veterinarian.  Keep out of reach of children and pets. Wash hands after use.

  • STORAGE AND HANDLING

    Store at controlled room temperature of 15 - 30° C (59 - 86° F).

  • QUESTIONS

    Questions or medical emergency: 1-800-224-7387

  • P007263 AHII

    image description

  • INGREDIENTS AND APPEARANCE
    0.1% KETOCONAZOLE, 0.15% SALICYLIC ACID 
    ear rinse solution, gel forming / drops
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:21091-269
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE0.1 
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.15 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21091-269-011 in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/08/2023
    Labeler - Sergeant's Pet Care Products LLC (876995171)
    Establishment
    NameAddressID/FEIBusiness Operations
    SV Labs Prescott Corporation185073996manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Sharon Bio-Medicine Limited675472749api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigma-Aldrich Manufacturing LLC829643423api manufacture
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