Hydrocortisone by Meridian Animal Health / DIVERSIFIED MANUFACTURING CORP / Tianjin Jinjin Pharmaceutical Co. LTD. HYDROCORTISONE spray

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Animal medication manufactured, distributed, or labeled by Meridian Animal Health, DIVERSIFIED MANUFACTURING CORP, Tianjin Jinjin Pharmaceutical Co. LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT:

Hydrocortisone USP 0.5% w/w.

PURPOSE:

DogMD Maximum Defense™ 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

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.

QUESTIONS

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)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 48688-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	0.59 g  in 118 g

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48688-031-01	118 g in 1 BOTTLE, SPRAY

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	Business Operations
DIVERSIFIED MANUFACTURING CORP		080569998	manufacture, label, pack, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Tianjin Jinjin Pharmaceutical Co. LTD.		529660490	api manufacture