Animal NDC 11695-6985-1 Cerasoothe P Anti-itch Mousse

Pramoxine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 11695-6985-1
Proprietary Name Cerasoothe P Anti-itch Mousse 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: Brush the fur then apply product on dry hair. Apply every 3 days for 2-3 weeks or as directed by your veterinarian. Wash hands after use.For localized application:​ Dispense 1 - 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 fur again.For whole body application:  Dispense 1 or 2 pumps onto your palm, then apply 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 fur again.Dosage:Under 11 lbs: 1 pump per 2 lbs11-88 lbs: 1 pump per 4 lbsOver 88 lbs: 1 pump per 6 lbsDosage may be doubled for long-haired dogs.For deeper cleansing, use Ceraven Pramoxine anti-itch shampoo.
Active Ingredient(s)
  • Pramoxine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • GLYCERIN (PDC6A3C0OX)
  • PEG-8 DIMETHICONE (GIA7T764OD)
  • POLYSORBATE 80 (6OZP39ZG8H)
  • POLOXAMER 184 (BIS92ZSF57)
  • ALOE VERA LEAF (ZY81Z83H0X)
  • AVENANTHRAMIDES (5PA41O4AIT)
  • CERAMIDE 1 (5THT33P7X7)
  • CERAMIDE EOS (CR0J8RN66K)
  • CERAMIDE NP (4370DF050B)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • WATER (059QF0KO0R)
  • GLYCERIN (PDC6A3C0OX)
  • PEG-8 DIMETHICONE (GIA7T764OD)
  • POLYSORBATE 80 (6OZP39ZG8H)
  • POLOXAMER 184 (BIS92ZSF57)
  • ALOE VERA LEAF (ZY81Z83H0X)
  • AVENANTHRAMIDES (5PA41O4AIT)
  • CERAMIDE 1 (5THT33P7X7)
  • CERAMIDE EOS (CR0J8RN66K)
  • CERAMIDE NP (4370DF050B)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • 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 P Anti-itch Mousse Images

Cerasoothe P Anti-itch Mousse 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 Mousse

Fragrance: Cucumber melon

Formulated for cats, dogs, and horses

A leave-on mousse with pramoxine to help relieve itching and skin irritations. Ceramides and avenanthramides are skin nourishing nutriients that moisturize and calm the skin. The also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.

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.


Indications & Usage



Indications: For use on cats, dogs and horses for the temporary relief of itching and skin irritations.

Directions for use: Brush the fur then apply product on dry hair. Apply every 3 days for 2-3 weeks or as directed by your veterinarian. Wash hands after use.

For localized application:​ Dispense 1 - 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 fur again.

For whole body application:  Dispense 1 or 2 pumps onto your palm, then apply 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 fur 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 Ceraven Pramoxine anti-itch shampoo.


Warnings And Precautions



Cautions: For external use on cats, dogs or 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: Store at room temperature. Do not freeze.


Other



QUESTIONS?

(855) 724-3461

Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com


Principal Display Panel - 6.8 Ounce (200 Ml) Bottle



Inspired by veteriarians

CeraSoothe PRAMOXINE

Anti-itch Mousse

Fragrance: Cucumber melon

Pramoxine HCl 1%

Formulated for cats, dogs, and horses

Keep out of reach of children

For animal use only

NDC: 11695-6985-1

Net Contents: 6.8 fl oz (200 mL)

covetrus


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