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

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, Hobe Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient:

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 of the body.

Stop use and ask veterinarian

if redness, irritation, or swelling persists or increases.

Directions

pre-bathe animal with a mild shampoo and dry thoroughly

if necessary, spread coat apart with fingers to expose irritated area to expose skin

massage lotion directly on the affected area. only a thin coat is necessary

small applications at frequent intervals give best results

for long haired breeds, it may be necessary to clip hair from irritated area to expose skin

when using this product- avoid in contact with the eyes.

individual results may vary

Other information

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

Inactive Ingredients

Deionized Water, Mineral Oil, Propylene Glycol, Isopropyl Myristate, Stearic Acid, Beeswax White, Cetyl Alcohol, Cocoamide DEA, Aloe Barbadensis Leal Juice, Carbomer, Sodium Borate, Diazolidinyl Urea, Methylparaben, Propylparaben, Fragrance.

Questions

(800) 530-2178

Package Labeling:

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone lotion

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 60754-925
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)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
STEARIC ACID (UNII: 4ELV7Z65AP)
WHITE WAX (UNII: 7G1J5DA97F)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 1342 (UNII: 809Y72KV36)
SODIUM BORATE (UNII: 91MBZ8H3QO)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60754-925-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/06/2014

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