Label: VETRASEB CERADERM P- pramoxine hydrochloride shampoo

  • NDC Code(s): 13985-438-08, 13985-438-16
  • Packager: MWI/VETONE
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated April 6, 2021

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    VetraSeb™ CeraDerm™ P

    Conditioning Shampoo

    Pramoxine HCl 1%

    Soothing Ant-itch Conditioning Shampoo for Dogs or Cats

    CUCUMBER MELON

    ACTIVE INGREDIENTS: Pramoxine HCI 1%.

    INACTIVE INGREDIENTS: Water, Sodium C14-16 Olefin Sulfonate, PEG-7 Glyceryl Cocoate, Sodium Chloride, Disodium Cocoamphodiacetate, Cocamidopropyl Betaine, Glycerin, Sodium Lactate, Avena Sativa (Oat) Kernal Extract, Ceramide EOP, Ceramide EOS, Ceramide NP, Carthamus Tinctorius (Safflower) Seed Oil, PEG-8, Laurate, Laureth-4, Fragrance, Citric Acid, Potassium Sorbate, Methylchloroisothiazolinone, Methylisothiazolinone.

    PROPERTIES: A conditioning shampoo 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:  Bathe 2-3 times per week until symptoms subside or as directed by your veterinarian. Wet the animal with cool water from the neck down and apply shampoo first on the skin abnormalities. Starting with a quarter-size amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Leave shampoo on for 10 minutes before rinsing with cool water. Wash hands after use. For a rinse-free solution between baths, use VetraSeb™ CeraDerm™ P Mousse.

  • WARNINGS AND PRECAUTIONS

    CAUTIONS: For external use on dogs and 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

    Available only through your veterinarian.

    Distributed by: MWI

    Boise, Idaho 83705

    www.VetOne.net

    QUESTIONS?

    1-800-999-0297

  • PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

    VetOne®

    VetraSeb™ CeraDerm™ P

    Conditioning Shampoo

    Pramoxine HCl 1%

    Soothing Anti-itch Conditioning Shampoo for Dogs or Cats

    CUCUMBER MELON

    For veterinary use only

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

    8 ounce bottle label

  • PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

    VetOne®

    VetraSeb™ CeraDerm™ P

    Conditioning Shampoo

    Pramoxine HCl 1%

    Soothing Anti-itch Conditioning Shampoo for Dogs or Cats

    CUCUMBER MELON

    For veterinary use only

    Net Contents: 16 FL. OZ. (473 mL)

    16 ounce bottle label

  • INGREDIENTS AND APPEARANCE
    VETRASEB CERADERM  P
    pramoxine hydrochloride shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13985-438
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    AVENANTHRAMIDES (UNII: 5PA41O4AIT)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CERAMIDE EOS (UNII: CR0J8RN66K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    LAURETH-4 (UNII: 6HQ855798J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-438-08237 mL in 1 BOTTLE, PLASTIC
    2NDC:13985-438-16473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/02/2021
    Labeler - MWI/VETONE (019926120)
    Registrant - Ceva Sante Animale (261126049)