PRAMODERM HC- pramoxine hydrochloride, hydrocortisone spray

PRAMODERM by

Drug Labeling and Warnings

PRAMODERM by is a Animal medication manufactured, distributed, or labeled by Henry Schein Animal Health, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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 & USAGE

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.

PRECAUTIONS

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 AND HANDLING

Storage: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PRAMODERM  HC
pramoxine hydrochloride, hydrocortisone spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 GLYCOLS (UNII: 3WJQ0SDW1A)
1,1'-OXYBIS(2-PROPANOL) (UNII: D5SV08985Z)
BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7210-1	237 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/15/2017

Labeler - Henry Schein Animal Health (603750329)

Registrant - Ceva Sante Animale (261126049)