Hydrocortisone by Twenty-First Century Healthcare Fund, L.L.C. / Westwood Laboratories Inc. HYDROCORTISONE spray

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Animal medication manufactured, distributed, or labeled by Twenty-First Century Healthcare Fund, L.L.C., Westwood Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Hydrocortisone Acetate 0.50%

Purpose

Anti-itch

Uses:

to soothe: itching flea bites dermatitis skin irritations eczema

Warnings

For external use only. Use for all adult dogs.

Keep out of Reach of Children

and animals to avoid unintended consumption. Do not use if product appears to be tampered with.

Do not use:

in eyes or nose where infection (pus) is present, since the drug may allow infection to be spread on pregnant animals.

Not for prolonged use. Do not apply to large areas areas of the body.

Stop use and ask veterinarian

if redness, irritation, or swelling persists or increases.

Directions

shake well before use

holds sprayer 4-6 inches away and spray directly on affected area

apply 2-3 times until relief is achieved

for best results, cleanse affected area prior to using this product

avoid contact with the eyes

individual results may vary

Other information

Store product in cool. dry place. Avoid temperatures above 86F.

Inactive Ingredients

Deionized Water, Propylene Glycol USP, Dimethyl Sulfoxide.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 60754-923
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60754-923-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/05/2014

Labeler - Twenty-First Century Healthcare Fund, L.L.C. (081289135)

Registrant - Twenty-First Century Healthcare Fund, L.L.C. (081289135)

Establishment
Name	Address	ID/FEI	Business Operations
Westwood Laboratories Inc.		069926483	api manufacture, manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Hobe Laboratories Inc.		782069702	api manufacture, manufacture