Label: BUROWS SOLUTION AND HYDROCORTISONE liquid

  • NDC Code(s): 11695-2209-1, 11695-2209-2, 11695-2209-6
  • Packager: Butler Animal health Supply, LLC dba Covetrus North America
  • 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 November 15, 2022

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

  • INFORMATION FOR OWNERS/CAREGIVERS

    For relief of inflammatory pruritic conditions in dogs

  • KEEP OUT OF REACH OF CHILDREN

    For animal use only
    Keep out of reach of children

  • Indications:

    A topical treatment for the relief of inflammatory pruritic conditions in dogs.

    Hydrocortisone provides antiinflammatory and anti-pruritic activity, while Burow’s Solution is an astringent for drying of moist dermatitis while providing cooling relief of discomfort.

  • Dosage:

    Apply 3 to 4 times daily.

  • Precautions:

    For topical use only. Not intended for deep-seated infections. Not for use in the eyes.

  • Ingredients:

    Each mL contains:
    Hydrocortisone.....................10 mg
    Burow’s solution...................20 mg

  • INACTIVE INGREDIENT

    In a water miscible base containing propylene glycol.

  • Contraindication:

    As with any topical hydrocortisone product, Burow’s solution and hydrocortisone should not be used in the presence of tuberculosis of the skin.

  • Storage:

    Store at controlled room temperature between 15°-30°C (59°-86°F). Keep container tightly closed when not in use.

  • WHEN USING

    image of eye clock

  • Net Contents:

    1 fl oz (30 mL)   Reorder #003574  AH-003574-02 REV: 1019

    2 fl oz   (60 mL)  Reorder #005612 AH-005612-01 REV: 0519

    16 fl oz (473 mL) Reorder #003605 AH-003605-02 REV: 0519

  • INFORMATION FOR OWNERS/CAREGIVERS

    Questions? (855) 724-3461

    Distributed by:
    Covetrus North America
    400 Metro Place North
    Dublin, OH 43017
    covetrus.com


    Manufactured by:
    First Priority, Inc.
    Elgin, IL 60123

  • 1 fl oz (30 mL)

    image of 1 oz bottle/case label

  • 2 fl oz (60 mL)

    image of 2 oz bottle/case label

  • 16 fl oz (473 mL)

    image of 16 oz bottle/case label

  • INGREDIENTS AND APPEARANCE
    BUROWS SOLUTION AND HYDROCORTISONE 
    burows solution and hydrocortisone liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-2209
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1.02 mg  in 1 mL
    ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM ACETATE0.073 mg  in 1 mL
    ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID0.0624 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-2209-212 in 1 CASE
    160 mL in 1 BOTTLE, DROPPER
    2NDC:11695-2209-612 in 1 CASE
    2473 mL in 1 BOTTLE, SPRAY
    3NDC:11695-2209-112 in 1 CASE
    330 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/10/2019
    Labeler - Butler Animal health Supply, LLC dba Covetrus North America (603750329)
    Establishment
    NameAddressID/FEIBusiness Operations
    FIRST PRIORITY INCORPORATED179925722manufacture, label