PRAMODERM 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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PRAMODERM HC SPRAY

Active Ingredients: pramoxine HCl 1%, hydrocortisone 1%.

Inactive Ingredients: water, SDA 40B 190 proof, glycerin, silicone emulsion, stearamidopropyl dimethylamine lactate, PEG-75 lanolin, sodium lactate, hydrolyzed oat protein, methylisothiazolinone.

Properties: Pramoderm HC Spray is a formulation containing pramoxine for antipruritic activity and hydrocortisone for anti-inflammatory benefits. It is beneficial for severe itching associated with skin inflammation.

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

Directions for Use: Shake well before use. Spray directly onto the target area. If needed, ruffle or part the hair to allow direct contact with the skin. Massage well. Do not allow the animal to lick the treated area until dry. Apply once a day for 2 to 3 weeks or as recommended by your veterinarian. May be used as part of a management plan as recommended by your veterinarian.

Cautions: For external use on dogs, cat and horses only. Avoid contact with the eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.

Storage: Store at room temperature. Do not freeze.

Questions? (855) 724-3461

Distributed by:
Henry Schein Animal Health
Dublin, OH 43017
www.henryscheinvet.com

PRINCIPAL DISPLAY PANEL - 8 fl oz (237 mL)

HENRY SCHEIN®

ANIMAL HEALTH

NDC 11695-7210-1

PRAMODERM HC SPRAY

Pramoxine HCl 1%, Hydrocortisone 1%

Soothing spray for dogs, cats and horses

8 fl oz (237 mL)

FOR ANIMAL USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

8 ounce bottle label

PRAMODERM  HC
pramoxine hydrochloride, hydrocortisone spray
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7210
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)  
STEARAMIDOPROPYL DIMETHYLAMINE LACTATE (UNII: 31Q9363QSX)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
OATMEAL (UNII: 8PI54V663Y)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOLAURETH-10 (UNII: K6BVH271CZ)  
SODIUM NONOXYNOL-4 SULFATE (UNII: 620W1JEN6V)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
1,1'-OXYBIS(2-PROPANOL) (UNII: D5SV08985Z)  
BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-7210-1237 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/15/201704/24/2020
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 4/2020
 
Butler Animal Health Supply, LLC dba Covetrus North America