Hydrocortisone: Product Information

HYDROCORTISONE- hydrocortisone and pramoxine hydrochloride spray
Stratford Care Usa, 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.

Active Ingredients: Hydrocortisone, 1%, Pramoxine Hydrochloride, 0.5%.

KEEP OUT OF THE REACH OF CHILDREN

Hydrocortisone Spray helps to Relieves Symptoms of Hot Spots, Bites and Skin Conditions So Your Pet Can Heal Quickly.

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.

Storage: Store at controlled room temperature.

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

Formulated for Dogs & Cats

FOR VETERINARY USE ONLY

Available Through Licensed Veterinarians Only.

Manufactured for:
Stratford Pharmaceuticals
Odessa, FL 33556
877-498-2002
www.stratfordrx.com

MADE IN THE USA

Packaging

HYDROCORTISONE hydrocortisone, pramoxine hydrochloride spray

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86069-120 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g in 100 mL PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 0.5 g in 100 mL

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL WATER ALCOHOL GLYCERIN PEG-75 LANOLIN OAT BENZYL ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:86069-120-04 118 mL in 1 BOTTLE, SPRAY None 2 NDC:86069-120-08 237 mL in 1 BOTTLE, SPRAY None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/15/2021

Labeler — Stratford Care Usa, Inc. (036650469)

Revised: 11/2021 Stratford Care Usa, Inc.