Burows Solution and Hydrocortisone: Product Information

BUROWS SOLUTION AND HYDROCORTISONE- hydrocortisone, aluminum acetate and acetic acid liquid
Butler Animal health Supply, LLC dba Covetrus North America

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.

For relief of inflammatory pruritic conditions in dogs

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

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.

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

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
(click image for full-size original)

2 fl oz (60 mL)

image of 2 oz bottle/case label
(click image for full-size original)

16 fl oz (473 mL)

image of 16 oz bottle/case label
(click image for full-size original)

BUROWS SOLUTION AND HYDROCORTISONE
burows solution and hydrocortisone liquid
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-2209
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1.02 mg in 1 mL
ALUMINUM ACETATE (ALUMINUM CATION) ALUMINUM ACETATE 0.073 mg in 1 mL
ACETIC ACID (ACETIC ACID) ACETIC ACID 0.0624 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11695-2209-2 12 BOTTLE, DROPPER in 1 CASE contains a BOTTLE, DROPPER
1 60 mL in 1 BOTTLE, DROPPER This package is contained within the CASE (11695-2209-2)
2 NDC:11695-2209-6 12 BOTTLE, SPRAY in 1 CASE contains a BOTTLE, SPRAY
2 473 mL in 1 BOTTLE, SPRAY This package is contained within the CASE (11695-2209-6)
3 NDC:11695-2209-1 12 BOTTLE, DROPPER in 1 CASE contains a BOTTLE, DROPPER
3 30 mL in 1 BOTTLE, DROPPER This package is contained within the CASE (11695-2209-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/10/2019
Labeler — Butler Animal health Supply, LLC dba Covetrus North America (603750329)
Establishment
Name Address ID/FEI Operations
FIRST PRIORITY INCORPORATED 179925722 manufacture, label

Revised: 01/2020 Butler Animal health Supply, LLC dba Covetrus North America

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