Animal NDC 11695-6984-1 Cerasoothe

Pramoxine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 11695-6984-1
Proprietary Name Cerasoothe What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Pramoxine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Butler Animal Health Supply, Llc Dba Covetrus North America
Product Type Otc Animal Drug
Usage Information
    Indications: For use on cats, dogs and horses 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 Ceraven Pramoxine anti-itch mousse.
Active Ingredient(s)
  • Pramoxine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • SODIUM C14-16 OLEFIN SULFONATE (O9W3D3YF5U)
  • PEG-7 GLYCERYL COCOATE (VNX7251543)
  • SODIUM CHLORIDE (451W47IQ8X)
  • DISODIUM COCOAMPHODIACETATE (18L9G3U51M)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • GLYCERIN (PDC6A3C0OX)
  • SODIUM LACTATE (TU7HW0W0QT)
  • AVENANTHRAMIDES (5PA41O4AIT)
  • CERAMIDE 1 (5THT33P7X7)
  • CERAMIDE EOS (CR0J8RN66K)
  • CERAMIDE NP (4370DF050B)
  • SAFFLOWER OIL (65UEH262IS)
  • PEG-8 LAURATE (762O8IWA10)
  • LAURETH-4 (6HQ855798J)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • WATER (059QF0KO0R)
  • SODIUM C14-16 OLEFIN SULFONATE (O9W3D3YF5U)
  • PEG-7 GLYCERYL COCOATE (VNX7251543)
  • SODIUM CHLORIDE (451W47IQ8X)
  • DISODIUM COCOAMPHODIACETATE (18L9G3U51M)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • GLYCERIN (PDC6A3C0OX)
  • SODIUM LACTATE (TU7HW0W0QT)
  • AVENANTHRAMIDES (5PA41O4AIT)
  • CERAMIDE 1 (5THT33P7X7)
  • CERAMIDE EOS (CR0J8RN66K)
  • CERAMIDE NP (4370DF050B)
  • SAFFLOWER OIL (65UEH262IS)
  • PEG-8 LAURATE (762O8IWA10)
  • LAURETH-4 (6HQ855798J)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Cerasoothe Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



CeraSoothe

PRAMOXINE

Anti-Itch Shampoo

Fragrance: Cucumber melon

Pramoxine HCl 1%

Formulated for cats, dogs and horses

A conditioning shampoo with pramoxine to help relieve itching and skin irritations. Ceramides and avenanthramides are skin nourishing nutrients that moisturize and calm the skin. They also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.

Active ingredient: 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.


Indications & Usage



Indications: For use on cats, dogs and horses 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 Ceraven Pramoxine anti-itch mousse.


Warnings And Precautions



Cautions: For external use on cats, dogs and horses 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.


Storage And Handling



STORAGE CONDITIONS: Store at room temperature. Do not freeze.


Other



Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

QUESTIONS?

(855) 724-3461


Principal Display Panel - 8 Ounce (237 Ml) Bottle



Inspired by veterinarians

CeraSoothe

PRAMOXINE

Anti-itch Shampoo

Fragrance: Cucumber melon

Pramoxine HCl 1%

Formulated for cats, dogs and horses

Keep out of reach of children

For animal use only

NDC: 11695-6984-1

Net contents: 8 fl oz (237 mL)


Principal Display Panel - 16 Ounce (473 Ml) Bottle



Inspired by veterinarians

CeraSoothe

PRAMOXINE

Anti-itch Shampoo

Fragrance: Cucumber melon

Pramoxine HCl 1%

Formulated for cats, dogs and horses

Keep out of reach of children

For animal use only

NDC: 11695-6984-2

Net contents: 16 fl oz (473 mL)


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.