Label: TOUGH SEAL HOT SPOT PLUS PAIN RELIEF- lidocaine spray

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

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Drug Label Information

Updated June 1, 2020

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  • DRUG FACTS

  • Active Ingredients:

    Lidocaine 1%

  • Purpose:

    Topical anasthetic

  • INDICATIONS & USAGE

    Uses: For the temporary relief of pain and itch in minor cuts, burns, scrapes, skin irritations, insect bites and sunburn

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Do not ingest. For use on dogs, cats, horses and other small animals.

    Keep away from children 2 years of age and younger.

  • DOSAGE & ADMINISTRATION

    Directions: Shake well then apply firm spray.

    DO NOT RUB IN. Allow a thin, clear film to set. Barrier is invisible once dry and safe if licked. Apply up to 3x a day for 7 days. Consult a veterinarian if condition worsens.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified water, ethanol, polyacrylate polymer, cellulose

  • SPL UNCLASSIFIED SECTION

    HOT SPOT PAIN RELIEF HYDROGEL

    Relieve & protect hot spots, rashes, skin irritations & more!

    340 SPRAYS

    Made in the USA

    TOUGH SEAL®

    Soothe, Seal & Protect®

    Questions? info@Kericure.com

    Kericure Inc. Baltimore, MD 21229

    KeriCure®.com

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    TOUGH SEAL HOT SPOT PLUS PAIN RELIEF 
    lidocaine spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:78280-702
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78280-702-2055 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/22/2020
    Labeler - Kericure Inc. (966638681)
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