HYDROCORTISONE- hydrocortisone acetate lotion
21st Century HealthCare Inc.

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.

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Hydrocortisone Lotion

Active Ingredient:

Hydrocortisone Acetate 0.50%

Purpose

Anti-itch

Uses:

to soothe: • skin irritations • itching • dermatitis • eczema • flea bites.

Warnings

For external use only on adult dogs.

Keep Out of Reach of Children

Keep out of reach of children and animals to avoid unintended consumption.

Do not use:

•in eyes or nose • not for prolonged use • do not use where infection (pus) is present, since the drug may allow inlection to be spread •

on pregnant animals • if product appears to be tampered with.

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

•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.

Other information

store product in cool. dry place. Avoid temperatures above 86 degrees F.

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.

PROUDLY MANUFACTURED FOR

21st Century Pet Nutrition

2119 S. Wilson Street, Tempe, AZ 85285 USA

www.21stcenturypet.com

Hydrocortisone Lotion MEDICATED (60754-925-04)

21st

Century

THE FUTURE OF PET HEALTH

ESSENTIAL
PET

NDC# 60754-925-04

Hydrocortisone

Lotion

MEDICATED

Relieves

Itching&

Soothes

Skin

Irritation

ALL DOGS

4.0 FL OZ

(Poids 118 ml)

Hydrocortisone Lotion

HYDROCORTISONE
hydrocortisone lotion

Product Information
Product Type	OTC ANIMAL DRUG LABEL	Item Code (Source)	NDC:60754-925
Route of Administration	Topical	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE ACETATE (HYDROCORTISONE)	HYDROCORTISONE ACETATE	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water
MINERAL OIL
PROPYLENE GLYCOL
ISOPROPYL MYRISTATE
STEARIC ACID
WHITE WAX
CETYL ALCOHOL
COCO DIETHANOLAMIDE
ALOE VERA LEAF
CARBOMER 1342
SODIUM BORATE
DIAZOLIDINYL UREA
METHYLPARABEN
PROPYLPARABEN

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

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

Labeler - 21st Century HealthCare Inc. (792342545)

Registrant - 21st Century HealthCare Inc. (792342545)

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

Revised: 2/2014

Document Id: 30bd05fc-4841-4b2d-ba53-4afdbcc017f4

Set id: 9ab06d29-c595-4e8b-b351-096ae69aa6c4

Version: 5

Effective Time: 20140226

21st Century HealthCare Inc.