Label: ALLERCAINE WITH BITTRAN II- lidocaine hydrochloride and benzalkonium chloride spray

  • NDC Code(s): 47171-010-04, 47171-010-12
  • Packager: Tomlyn Products, a Division of Vetoquinol USA, Inc.
  • 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 October 5, 2018

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

  • VETERINARY INDICATIONS

    Hot Spot Spray by Tomlyn® is an antiseptic, anti-itch spray that calms, soothes and temporarily relieves pain and itching caused by insect bites and other minor allergic problems in dogs. It also helps prevent infection in minor cuts, scrapes and burns.

    Hot Spot Spray with Bittran™ II (a safe, bitter substance that discourages animals from licking and biting irritated areas) can be used daily to help control compulsive scratching and spot chewing problems in dogs. Hot Spot Spray adheres easily to the skin (no messy run-off) and vanishes, leaving your dog's skin and coat dry and non-sticky.

  • DIRECTIONS:

    Spray on localized irritated areas as required. Dogs who are highly allergic should be bathed regularly for optimal skin and tissue health.

  • PRECAUTIONS:

    Consult your veterinarian immediately if swelling occurs, or if redness and irritation persist for five days or more. Avoid contact with eyes. Avoid excessive application. Do not apply to entire body or to large areas of broken skin. Wash hands after use.

    FOR EXTERNAL ANIMAL USE ONLY.

    DO NOT USE ON CATS.

    KEEP OUT OF REACH OF CHILDREN AND PETS.

  • ACTIVE INGREDIENTS:

    Lidocaine hydrochloride2.4%
    Benzalkonium chloride0.1%

    Compounded in a vanishing liquid base containing PEG-75 lanolin, aloe vera gel, allantoin and denatonium benzoate (Bittran™ II), among other ingredients. Stabilized at a pH of normal animal skin.

  • QUESTIONS?

    Manufactured for:
    Tomlyn® Products
    Division of Vetoquinol USA, Inc.
    Ft. Worth, TX (USA) 76137
    1 (877) 580-7729
    www.tomlyn.com

    411388
    14

  • SPL UNCLASSIFIED SECTION

    100%
    SATISFACTION
    GUARANTEED!

    Manufactured in the USA with
    domestic and imported ingredients

    Lot No:
    Exp. Date

  • SPL UNCLASSIFIED SECTION

    Learn more about the
    story of Tom & Lyn at:
    www.tomlyn.com

    Promote healing and deter chewing of
    wounds with Hot Spot Spray for dogs.

    - Tom & Lyn

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    since 1976
    tomlyn®
    VETERINARY SCIENCE

    NDC 47171-010-04

    HOT SPOT SPRAY
    WITH BITTRAN II™ FOR DOGS

    ALLERCAINE™

    ANTISEPTIC • ANTI-ITCH

    • Soothes 'hot spots' & insect bites
    • Helps control scratching & spot
      chewing
    • Lidocaine reduces pain & itching
    • Benzalkonium chloride helps
      prevent infection

    ALL
    DOGS

    Veterinarian formulated.
    Trusted since 1976.

    NET CONTENTS:
    4 fl oz (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ALLERCAINE WITH BITTRAN II 
    lidocaine hydrochloride and benzalkonium chloride spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:47171-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous24 mg  in 1 mL
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    PEG-75 Lanolin (UNII: 09179OX7TB)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Hydroxymethyl Cellulose (UNII: 273FM27VK1)  
    Cetrimonium Bromide (UNII: L64N7M9BWR)  
    Allantoin (UNII: 344S277G0Z)  
    Denatonium Benzoate (UNII: 4YK5Z54AT2)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47171-010-12355 mL in 1 BOTTLE, PLASTIC
    2NDC:47171-010-04118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER12/29/1999
    Labeler - Tomlyn Products, a Division of Vetoquinol USA, Inc. (037730194)
    Registrant - Vetoquinol USA, Inc. (106824209)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Pharmaceuticals and Cosmetics, Inc.038023805MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    R. Mason (Chemicals) Ltd.213246044API MANUFACTURE