Hydrocortisone: Product Information

HYDROCORTISONE- hydrocortisone spray
Meridian Animal Health

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.

ACTIVE INGREDIENT:

Hydrocortisone USP 0.5% w/w.

PURPOSE:

DogMD Maximum Defenseā„¢ Hydrocortisone Spray provides quick relief from itching and rashes and other minor skin irritations. Safe for use on puppies at least 12 weeks of age.

WARNINGS:

For external use on dogs only.
Avoid contact with eyes or mucous membranes.
In case of contact, flush eyes with water and seek medical attention if irritation persists.

KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DIRECTIONS:

Shake well before use. Hold spray 6-8 inches from affected area and apply directly. Apply 2-3 times per day, not to exceed 10 consecutive days. If symptoms persist or worsen, discontinue use of this product and consult a veterinarian. Wash hands after use.

INACTIVE INGREDIENTS:

Chloroxylenol, Denatured Alcohol, FD&C Blue #1, Hamamelis Extract, Lactic Acid, Menthol, and Propylene Glycol.

OTHER INFORMATION:

Store at room temperature.

In Case of Emergency, call: 1-877-416-7330
Non-Emergency, call: 1-888-814-4738 (4PET)
If you have questions or comments about this product, please write:
Consumer Response
P.O. Box 540224, Omaha, NE 68154-0224

PACKAGE LABEL

P068490 RRRD

Distributed by:

Meridian Animal Health, Omaha, NE 68138

NDC #48688-031-01

Net Contents: 4 fl oz (118 mL)

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HYDROCORTISONE
hydrocortisone spray
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:48688-031
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 0.59 g in 118 g
Product Characteristics
Color blue Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:48688-031-01 118 g in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/28/2015
Labeler — Meridian Animal Health (012572873)
Registrant — Meridian Animal Health (012572873)
Establishment
Name Address ID/FEI Operations
DIVERSIFIED MANUFACTURING CORP 080569998 manufacture, label, pack, relabel, repack
Establishment
Name Address ID/FEI Operations
Tianjin Jinjin Pharmaceutical Co. LTD. 529660490 api manufacture

Revised: 08/2019 Meridian Animal Health

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