HYDROCORTISONE- hydrocortisone, pramoxine hydrochloride spray

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Animal medication manufactured, distributed, or labeled by Animal Pharmaceuticals, Stratford Care Usa, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Hydrocortisone, USP ............................... 1% 
Pramoxine Hydrochloride, USP ............ 0.5% 

Purpose

Anti-Inflammatory
Topical Anesthetic

Inactive Ingredients

Propylene Glycol, Water, SD Alcohol 40B, Glycerin, PEG-75 Lanolin, Hydrolyzed Oats, Benzyl Alcohol.

Uses

helps to relieve symptoms of hot spots, bites and skin conditions so your pet can heal quickly.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of contact with eyes or mucous membranes, flush with copious amounts of water for 5-10 minutes. If irritation persists seek medical attention immediately.

Directions for Use

Spray directly onto the affected area(s) up to 3 times daily, or as directed by veterinarian. Do not allow animal to lick the treated areas until dry to prevent ingestion.

Precautions

Avoid contact with eyes or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

Cautions

If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

SPL UNCLASSIFIED SECTION

For Relief Of Skin Conditions Associated With Hot Spots, Allergies, And Dermatitis

Formulated for Dogs, Cats & Horses

At Animal Pharmaceuticals we strive to provide the best nutritional and topical treatments for your pet by going above and beyond...and we don't stop there. We know that caring for your pet is just as important as caring for your own health, so we've developed and implemented systems that make things easier on you and convenient for your Veterinarian.

OUR ASSURANCE

Animal Pharmaceutical products are designed with our proprietary technology that helps retrieve and sustain the nutrients and healthful ingredients. Our proprietary formulation enhances the effects of functional ingredients and penetrates the skin and the effective areas to exert the corrective results.

Additionally, and as always, you’ll find that all our bottles and containers are made of recyclable plastic. Please help us help the environment by recycling.

ALL PRODUCTS ARE MADE IN THE U.S.A. AND 100% QUALITY GUARANTEED.

To learn more about our products, visit:
www.anmpharm.com

SOLD EXCLUSIVELY THROUGH LICENSED VETERINARIANS

MANUFACTURED FOR
Animal Pharmaceuticals

AX0090
REV 0921
AX0091
REV 1021

MADE IN THE USA

Packaging

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone, pramoxine hydrochloride spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 68898-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-75 LANOLIN (UNII: 09179OX7TB)
OAT (UNII: Z6J799EAJK)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68898-127-04	118 mL in 1 BOTTLE, SPRAY
2	NDC: 68898-127-08	237 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/04/2021

Labeler - Animal Pharmaceuticals (166472444)

Registrant - Stratford Care Usa, Inc. (036650469)