Label: BENZALKONIUM CHLORIDE- hot spot skin remedy gel

  • NDC Code(s): 21091-001-01
  • Packager: Sergeants Pet Care Products LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated June 7, 2022

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  • ACTIVE INGREDIENT:

    Benzalkonium Chloride

  • PURPOSE

    PURPOSE:  SENTRY Hot Spot Skin Remedy for dogs is formulated to be effective for skin irritations.  Specifically kills staphylococcus intermedius bacteria.  Hot spots in dogs are commonly associated with staphylococcus intermedius.  Kills topical bacteria, fungus and viruses.  SENTRY Hot Spot Skin Remedy is indicated for superficial cuts, scrapes, and abrasions.  Best of all, SENTRY Hot Spot Skin Remedy contains no alcohol and is a non-stinging formula.

    Signs of Hot Spots:  Hot spots are usually accompanied by incessant rubbing, scratching and biting due to intense itching.  Other signs are moist reddened areas, hair loss, and flaky skin.  Hot spots are usually warm to the touch.

  • WARNINGS:

    Do not use on puppies under 6 weeks of age.

    For external use only on dogs.

    KEEP OUT OF REACH OF CHILDREN AND PETS

  • DIRECTIONS FOR USE:

    Trim the hair around the sore. Wash the area with mild soap and water, rinse and pat dry. Apply to affected area using the applicator tip. Does not require dabbing on with a cotton ball. Consult a veterinarian if any problems persist or are of concern.

  • STORAGE AND HANDLING

    Store below 30°C (86°F)

  • INACTIVE INGREDIENTS:

    Allantoin, Cetrimonium Chloride, Citric Acid, Cocamidopropyl Betain, Green 5 (Cl 61570), Hydroxypropyl Methyloellubse, Methylparaben, Octoxynol 9, Propylene Glycol, Propylparaben, Sodium Hydroxide, Triethanolamine, Water.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

    image description

  • INGREDIENTS AND APPEARANCE
    BENZALKONIUM CHLORIDE 
    hot spot skin remedy gel
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:21091-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorblue (blue/green) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21091-001-01118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/17/2022
    Labeler - Sergeants Pet Care Products LLC (876995171)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lonza Biologics Inc093149750api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Straight Arrow Products Inc052165154manufacture, label, pack
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