Label: HYDROCORTISONE spray

  • NDC Code(s): 60754-923-04
  • Packager: Twenty-First Century Healthcare Fund, L.L.C.
  • 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 April 28, 2020

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

  • Drug Facts

  • Active Ingredients:

    Hydrocortisone Acetate 0.50%

    Purpose

    Anti-itch

  • Uses:

    to soothe: • itching • flea bites • dermatitis • skin irritations • eczema

  • Warnings

    For external use only. Use for all adult dogs.

    Keep out of Reach of Children

    and animals to avoid unintended consumption. Do not use if product appears to be tampered with.

    Do not use:

    • in eyes or nose • where infection (pus) is present, since the drug may allow infection to be spread • on pregnant animals.

    Not for prolonged use. Do not apply to large areas areas of the body.

    Stop use and ask veterinarian

    if redness, irritation, or swelling persists or increases.

  • Directions

    • shake well before use

    • holds sprayer 4-6 inches away and spray directly on affected area

    • apply 2-3 times until relief is achieved

    • for best results, cleanse affected area prior to using this product

    • avoid contact with the eyes

    • individual results may vary

  • Other information

    Store product in cool. dry place. Avoid temperatures above 86F.

  • Inactive Ingredients

    Deionized Water, Propylene Glycol USP, Dimethyl Sulfoxide.

  • PRINCIPAL DISPLAY PANEL

    label6

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:60754-923
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60754-923-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/05/2014
    Labeler - Twenty-First Century Healthcare Fund, L.L.C. (081289135)
    Registrant - Twenty-First Century Healthcare Fund, L.L.C. (081289135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Westwood Laboratories Inc.069926483api manufacture, manufacture