PRAMOXINE HC- pramoxine hydrochloride, hydrocortisone spray 
Butler Animal Health Supply, LLC dba Covetrus North America

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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Pramoxine HC Spray

ACTIVE INGREDIENTS: Hydrocortisone 1%, pramoxine hydrochloride 1%.

INACTIVE INGREDIENTS: Propylene glycol, water, SD alcohol 40B, glycerin, PEG-75 lanolin, hydrolyzed oats, benzyl alcohol.

PROPERTIES: Pramoxine HC anti-itch spray is a non-stinging formula to help provide relief from itching caused by insect bites, hot spots and other minor skin irritations.  Pramoxine hydrochloride is a mild numbing agent.  Hydrocortisone, lanolin and oatmeal soothe irritated skin.

INDICATIONS: For use on dogs, cats, or horses only. For the temporary relief of pruritus and skin irritations.

DIRECTIONS FOR USE: Shake well before use.  Apply on dry fur 1-3 times per day for 2-3 weeks or as directed by your veterinarian.  Part the fur and spray directly on the affected area(s) of the skin.  Gently smooth product on to the skin to ensure full coverage.  Do not allow the animal to lick the treated area.

CAUTIONS: For external use on dogs, cats, and horses only. Avoid contact with the eyes. If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.  Wash hands after use.

STORAGE: Store at room temperature. Do not freeze.

Distributed by: 

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

Questions? (855) 724-3461

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

NDC: 11695-7220-1

Pramoxine HC

Anti-itch Spray

Hydrocortisone 1%

pramoxine hydrochloride 1%

Soothing spray for 

dogs, cats, and horses

For animal use only

Keep out of reach of children

SHAKE WELL BEFORE USE

Net Contents: 8 FL. OZ. (237 mL)

8 ounce bottle label

PRAMOXINE  HC
pramoxine hydrochloride, hydrocortisone spray
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
OATMEAL (UNII: 8PI54V663Y)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-7220-1237 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/27/2020
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 4/2020
Document Id: b43bfe17-6566-45a5-a20b-07c9b105da56
Set id: f9af28b6-2e76-4af1-b24b-1bc38d4e1953
Version: 1
Effective Time: 20200427
 
Butler Animal Health Supply, LLC dba Covetrus North America