Label: HARTZ GROOMERS BEST- hydrocortisone spray 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 04/13

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

  • ACTIVE INGREDIENT

    Active Ingredient

    0.5% Hydrocortisone, USP 

    Close
  • PURPOSE

    Purpose

    Anti-itch

    Close
  • INDICATIONS & USAGE

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

    Close
  • WARNINGS

    Warnings

    For external use on adult dogs and cats only.

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

    Close
  • DO NOT USE

    Do not use ▪In eyes or nose ▪not for prolonged use ▪do not apply to large areas of the bodydo 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

    Close
  • STOP USE

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

    Close
  • 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

    Close
  • SPL UNCLASSIFIED SECTION

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

    Close
  • INACTIVE INGREDIENT

    Inactive Ingredients

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

    Close
  • INGREDIENTS AND APPEARANCE
    HARTZ  GROOMERS BEST
    hydrocortisone spray
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:43201-3056
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    WATER  
    EDETATE DISODIUM  
    PROPYLENE GLYCOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43201-3056-5 147 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/01/2012
    Labeler - The Hartz Mountain Corporation (058109158)
    Close