HYDROCORTISONE- hydrocortisone spray 
Twenty-First Century Healthcare Fund, L.L.C.

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 Spray

Drug Facts

Active Ingredients:

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 areas of the body.

Stop use and ask veterinarian

if redness, irritation, or swelling persists or increases.

Directions

• shake well before use

• holds sprayer 4-6 inches away and spray directly on affected area

• apply 2-3 times until relief is achieved

• for best results, cleanse affected area prior to using this product

• avoid contact with the eyes

• individual results may vary

Other information

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

Inactive Ingredients

Deionized Water, Propylene Glycol USP, Dimethyl Sulfoxide.

label6

HYDROCORTISONE 
hydrocortisone spray
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:60754-923
Route of AdministrationTopical
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60754-923-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/05/201404/30/2020
Labeler - Twenty-First Century Healthcare Fund, L.L.C. (081289135)

Revised: 10/2021
Document Id: 529d45aa-6b07-40e2-a61f-3a3719705ce2
Set id: bbec8582-4ef0-41d3-b1eb-954ec63bfe5b
Version: 12
Effective Time: 20211028
 
Twenty-First Century Healthcare Fund, L.L.C.