VETRASEB CERADERM P MOUSSE- pramoxine hydrochloride liquid

VetraSeb CeraDerm by

Drug Labeling and Warnings

VetraSeb CeraDerm 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™ CeraDerm™ P

Soothing Anti-itch Leave-on Mousse for Dogs or Cats

CUCUMBER MELON

For veterinary use only

ACTIVE INGREDIENTS: Pramoxine HCl 1%.

INACTIVE INGREDIENTS: Water, Glycerin, PEG-8 Dimethicone, Polysorbate 80, Poloxamer 184, Sodium Lactate, Aloe Barbadensis (Aloe) Leaf Juice, Avena Sativa (Oat) Kernel Extract, Ceramide EOP, Ceramide EOS, Ceramide NP, Fragrance, Potassium Sorbate, Methylisothiazolinone.

PROPERTIES: A leave-on mousse with pramoxine to help relieve itching. Skin nourishing nutrients moisturize and calm the skin. They also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.

INDICATIONS & USAGE

INDICATIONS: For use on dogs or cats for the temporary relief of itching and skin irritations.

DIRECTIONS FOR USE: Shake well before use.  Brush the fur then apply product. Apply every 3 days for 2-3 weeks or as directed by your veterinarian. Wash hands after use.

For localized application:​ Dispense 1 to 2 pumps onto your palm, then apply on the targeted area(s). Massage into the skin until fully penetrated. Do not rinse, let air dry. Once dry, brush the haircoat again.

For whole body application:  Dispense 1 or 2 pumps onto your palm and massage on the skin and hair. Massage into the skin until fully penetrated. Repeat as necessary to cover the whole body, avoiding the eyes and mouth. Do not rinse, let air dry. Once dry, brush the haircoat again.

Dosage:

Under 11 lbs: 1 pump per 2 lbs

11-88 lbs: 1 pump per 4 lbs

Over 88 lbs: 1 pump per 6 lbs

Dosage may be doubled for long-haired dogs. For deeper cleansing, use VetraSeb™ CeraDerm™ P Conditioning Shampoo.

WARNINGS AND PRECAUTIONS

CAUTIONS: For external use on dogs or cats only. Avoid contact with 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 reach of children.

STORAGE AND HANDLING

STORAGE CONDITIONS: 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 - 6.8 OUNCE (200 mL) Bottle

VETone®

VetraSeb™ CeraDerm™ P

Mousse

Pramoxine HCl 1%

Soothing Anti-itch Leave-on Mousse for Dogs or Cats

CUCUMBER MELON

For veterinary use only

Net Contents: 6.8 FL. OZ. (200 mL)

INGREDIENTS AND APPEARANCE

VETRASEB CERADERM  P MOUSSE
pramoxine hydrochloride liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 13985-439
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLOXAMER 184 (UNII: BIS92ZSF57)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13985-439-68	200 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/22/2021

Labeler - MWI/VETONE (019926120)

Registrant - Ceva Sante Animale (261126049)