VETRASEB HC- pramoxine hydrochloride, hydrocortisone spray

VetraSeb by

Drug Labeling and Warnings

VetraSeb by is a Animal medication manufactured, distributed, or labeled by MWI/VetOne, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

VetraSeb HC Spray

ACTIVE INGREDIENTS: Pramoxine HCI 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: VetraSeb™ 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 and cats only. For the temporary relief of pruritus and skin irritations.

DIRECTIONS FOR 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.

WARNINGS AND PRECAUTIONS

CAUTIONS: For external use on dogs and cats 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.

WARNING: Keep out of the reach of children.

STORAGE AND HANDLING

STORAGE: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

Distributed by: MWI

Boise, Idaho 83705

www.VetOne.net

Questions?

1-800-999-0297

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

NDC: 13985-732-08

VETONE®

VetraSeb™ HC

Spray

Pramoxine HCl 1%, Hydrocortisone 1%

Soothing Spray

for Dogs and Cats

For veterinary use only

8 FL. OZ. (237 mL)

INGREDIENTS AND APPEARANCE

VETRASEB  HC
pramoxine hydrochloride, hydrocortisone spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13985-732
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)
PEG-75 LANOLIN (UNII: 09179OX7TB)
SODIUM LACTATE (UNII: TU7HW0W0QT)
OATMEAL (UNII: 8PI54V663Y)
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: 13985-732-08	237 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2017

Labeler - MWI/VetOne (019926120)

Registrant - Ceva Sante Animale (261126049)