SENTRY HYDROCORTISONE- hydrocortisone spray

SENTRY Hydrocortisone by

Drug Labeling and Warnings

SENTRY Hydrocortisone by is a Animal medication manufactured, distributed, or labeled by Sergeant's Pet Care Products, Inc., Diversified Manufacturing Corporation, Tiajin Jinjin Pharmaceuticals Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS AND USAGE:

SENTRY Hydrocortisone Spray for dogs provides quick relief from itching and rashes and other minor skin irritations. Safe for use on puppies at least 12 weeks of age.

DIRECTIONS FOR USE:

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. Discontinue use should symptoms persist, consult a veterinarian.

CAUTION:

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

KEEP OUT OF REACH OF CHILDREN

WARNING:

Wash hands after use. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

ACTIVE INGREDIENT:

Hydrocortisone USP 0.5% w/w

OTHER INGREDIENTS:

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

STORAGE AND HANDLING:

Store at room temperature.

HOW SUPPLIED:

Net 4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENTRY HYDROCORTISONE 
hydrocortisone spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 21091-235
Route of Administration	TRANSDERMAL

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

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	57.30 mL  in 118 mL
ALCOHOL (UNII: 3K9958V90M)	60.0 mL  in 118 mL
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)	0.118 mL  in 118 mL
LACTIC ACID (UNII: 33X04XA5AT)	0.117 mL  in 118 mL
CHLOROXYLENOL (UNII: 0F32U78V2Q)	0.0118 mL  in 118 mL
MENTHOL (UNII: L7T10EIP3A)	0.0118 mL  in 118 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.0003 mL  in 118 mL

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21091-235-04	118 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/12/2012

Labeler - Sergeant's Pet Care Products, Inc. (876995171)

Establishment
Name	Address	ID/FEI	Business Operations
Diversified Manufacturing Corporation		185073996	manufacture, pack, label

Establishment
Name	Address	ID/FEI	Business Operations
Tiajin Jinjin Pharmaceuticals Co. Ltd.		529660490	api manufacture