Label: HARTZ GROOMERS BEST- hydrocortisone spray

  • NDC Code(s): 43201-3056-5
  • Packager: The Hartz Mountain Corporation
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 22, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient

    0.5% Hydrocortisone, USP 

  • PURPOSE

    Purpose

    Anti-itch

  • INDICATIONS & USAGE

    Uses to soothe ▪ Itching ▪Flea bites ▪Dermatitis ▪Skin Irratations ▪Eczema

  • WARNINGS

    Warnings

    For external use on adult dogs and cats only.

    Keep out of the reach of children and animnals to avoid unintended consumption.

  • DO NOT USE

    Do not use ▪In eyes or nose ▪not for prolonged use ▪do not apply to large areas of the body ▪do not use where infection (pus) is present, since the drug may allow the infection to be spread ▪on pregnant animals ▪ if product appears to be tasmpered with

  • STOP USE

    stop use and ask a veterinarian if redness, irritations, or swelling persists or increases

  • DOSAGE & ADMINISTRATION

    Directions: Shake well before use. Hold sprayer 4 to 6 inches from affected area and apply directly. Apply 2-3 times daily to irritated area until relief is achieved. For best results, cleanse affected area prior to use when using this product. Avoid contact with eyes

  • SPL UNCLASSIFIED SECTION

    Other informationStore product in cool, dry place. Avoid temperatures above 86F

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aloe Vera Gel, Deionized Water, Disodium EDTA, Propylene Glycol

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HARTZ  GROOMERS BEST
    hydrocortisone spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:43201-3056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43201-3056-5147 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2012
    Labeler - The Hartz Mountain Corporation (058109158)
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