HYDROCORTISONE- hydrocortisone acetate shampoo
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 Shampoo

Canine Aspirin

Active Ingredients:

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

•rinse pet with warm water until coat is thoroughly wet

•massage a handlul of shampoo (less lor small pets) thoroughly into the coat

•continue massaging and add water during the process to make sure the shampoo is tho roughly distributed through the coat

•leave the pet in lather for 5-10 minutes keeping the pet warm and out ol drafts

•rinse thoroughly and dry

•for best results use at least twice a week or as directed by a veterinarian

•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, Sodium Lauryl Ether Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine. Cocamidopropylamine Oxide, PEG-3 Distearate,

Aloe Barbadensis Leal Juice, Cocamide DEA. Triethanolamine. Lactic Acid, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance.

PROUDLY MANUFACTURED FOR

21st Century Pet Nutrition

2119 S. Wilson Street, Tempe, AZ 85285 USA

www.21stcenturypet.com

Hydrocortisone Shampoo MEDICATED (60754-920-08)

21st

Century

THE FUTURE OF PET HEALTH

ESSENTIAL
PET

NDC# 60754-920-08

Hydrocortisone

Shampoo

MEDICATED

Relieves

Itching&

Soothes

Skin

Irritation

ALL DOGS

8.0 FL OZ

(Poids 237 ml)

Hydrocortisone Shampoo

HYDROCORTISONE
hydrocortisone shampoo

Product Information
Product Type	OTC ANIMAL DRUG LABEL	Item Code (Source)	NDC:60754-920
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
SODIUM LAURETH-2 SULFATE
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER
COCAMIDOPROPYL BETAINE
COCAMIDOPROPYLAMINE OXIDE
PEG-3 DISTEARATE
ALOE VERA LEAF
COCO DIETHANOLAMIDE
TROLAMINE
LACTIC ACID
DMDM HYDANTOIN
METHYLPARABEN
PROPYLPARABEN

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60754-920-08	237 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

Revised: 2/2014

Document Id: 54b8495b-c190-4f40-b4d3-1c39730ca910

Set id: a7e9ab8d-6a46-458e-98da-149a3915df44

Version: 2

Effective Time: 20140225

21st Century HealthCare Inc.