Label: HYDROCORTISONE- hydrocortisone acetate lotion

  • NDC Code(s): 86131-102-04
  • Packager: Whitebridge Pet Brands
  • Category: OTC ANIMAL DRUG LABEL

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 December 12, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DRUG FACTS

    Active Ingredients 

    Hydrocortisone Acetate

    (Equivalent to Hydrocortisone 0.5%)

  • PURPOSE

    Purpose

    Antipruritic (Anti-Itch)

    Anti-Inflammatory

  • Uses

    soothes flea bites, dermatitis, skin irritations, inflammations, moist eczema & itching.

  • Warnings

    For external use on dogs only.

    Avoid contact with eyes (dogs or people)

    Keep this and all pet products out of reach of childern. 

  • Directions

    pre-bathe animal with a mild shampoo and dry thoroughly.  If necessary, spread coat apart with fingers to expose irritated area.  Massage lotion directly on the affected area.  Only a thin coat is necessary.  Small applications at frequent intervals gives the best results.  For long-haired breeds, it may be necessary to clip hair from the irritated area to expose skin.  Use an Elizabethan Collar (E-Collar), if necessary, to keep pet from licking the medicine while being treated. 

  • Other information

    store at temperature between 66-77 F

  • Inactive ingredients

    Aloe Barbandensis Leaf Juice, Beeswax White, Carbomer, Cetyl Alcohol, Ethylhexyglycerin, Fragrance/Parfum, Isopropyl Myristate, Mineral Oil, Phenoxyethanol, Propanediol, Sodium Borate, Stearic Acid, Water (Aqua).

  • SPL UNCLASSIFIED SECTION

    SOOTHING RELIEF!

    Dogswell Hydrocortisone Lotion helps heal skin irritations, inflammations, wet eczema, and flea bite dermatitis.  This soothing lotion helps relieve itching and swelling. 

    DOGSWELL.COM

    Facebook.com/Dogswell 888-55-8833

    Distrubuted by Whitebridge Pet Brands,

    St. Louis, MO 63141

    2020 Whitebridge. All Right Reserved.

    NDC# 86131-102-04

  • PRINCIPAL DISPLAY PANEL

    REMEDY RECOVERY

    DOGSWELL

    HYDROCORTISONE LOTimage descriptionIONimage descriptionimage description

    for DOGS

    REDUCES SWELLING STOPS ITCHING

    For Skin Irritations, Inflammation, Moist Eczema & Itching

    Net Contents: 118 ml. (4 fl. oz.)

    image description
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone acetate lotion
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86131-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE0.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86131-102-04118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/10/2020
    Labeler - Whitebridge Pet Brands (138434316)
    Registrant - Whitebridge Pet Brands (138434316)
    Establishment
    NameAddressID/FEIBusiness Operations
    Westwood Laboratories LLC832280635manufacture, api manufacture