Animal NDC 11695-6989-2 Cerasoothe Sa Ear Cleaner

Salicylic Acid

Animal Product Information

Field Name Field Value
Animal NDC Code 11695-6989-2
Proprietary Name Cerasoothe Sa Ear Cleaner 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 Salicylic Acid 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 to cleanse, deodorize and dry the ear canal.Directions for use: Ask your veterinarian which of the two following protocols is best for your pet:1) Moisten a cotton ball with solution and place at the entrance of the ear canal; or2) Hold ear flap upward and fill with solution.Then gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away visible debris and excess solution with a clean cotton ball. Wask hands after use.
Active Ingredient(s)
  • Salicylic Acid
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • GLYCERIN (PDC6A3C0OX)
  • BENZOIC ACID (8SKN0B0MIM)
  • BENZYL ALCOHOL (LKG8494WBH)
  • DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (0MBZ20845F)
  • NONOXYNOL-12 (6NR43D77O6)
  • DOCUSATE SODIUM (F05Q2T2JA0)
  • LACTIC ACID (33X04XA5AT)
  • ALOE VERA LEAF (ZY81Z83H0X)
  • AVENANTHRAMIDES (5PA41O4AIT)
  • CERAMIDE 1 (5THT33P7X7)
  • CERAMIDE EOS (CR0J8RN66K)
  • CERAMIDE NP (4370DF050B)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • EDETATE SODIUM (MP1J8420LU)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • GLYCERIN (PDC6A3C0OX)
  • BENZOIC ACID (8SKN0B0MIM)
  • BENZYL ALCOHOL (LKG8494WBH)
  • DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (0MBZ20845F)
  • NONOXYNOL-12 (6NR43D77O6)
  • DOCUSATE SODIUM (F05Q2T2JA0)
  • LACTIC ACID (33X04XA5AT)
  • ALOE VERA LEAF (ZY81Z83H0X)
  • AVENANTHRAMIDES (5PA41O4AIT)
  • CERAMIDE 1 (5THT33P7X7)
  • CERAMIDE EOS (CR0J8RN66K)
  • CERAMIDE NP (4370DF050B)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • EDETATE SODIUM (MP1J8420LU)
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 Sa Ear Cleaner 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 SA

Otic Cleansing Solution

Fragrance: Cucumber melon

Formulated for cats, dogs, and horses

Cleans dries and deodorizes the ear canal. Contains salicylic acid, a beta-hydroxy acid (BHA) to exfoliate and penetrate dead skin cells, wax build-up and dirt. 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 ingredients: Salicylic acid 0.15%.

Inactive ingredients: Water, SD alcohol 40-B, propylene glycol, glycerin, benzoic acid, benzyl alcohol, disodium oleamido MIPA sulfosuccinate, nonoxynol-12, diethylhexyl sodium sulfosuccinate, lactic acid, aloe barbadensis (aloe vera) leaf juice, avena sative (oat) kernel oil, ceramide EOP, ceramide EOS, ceramide NP, fragrance, potassium sorbate, tetrasodium EDTA.


Indications & Usage



Indications: For use on cats, dogs, and horses to cleanse, deodorize and dry the ear canal.

Directions for use: Ask your veterinarian which of the two following protocols is best for your pet:

1) Moisten a cotton ball with solution and place at the entrance of the ear canal; or

2) Hold ear flap upward and fill with solution.

Then gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away visible debris and excess solution with a clean cotton ball. Wask hands after use.


Warnings And Precautions



Cautions: For external use on cats, dogs, and horses only. Avoid contact with the eyes.  If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Do not use with a suspected ruptured eardrum.


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 - 8 Ounce (237 Ml) Bottle



Inspired by veterinarians

CeraSoothe SA

Otic Cleansing Solution

Fragrance: Cucumber melon

Salicylic Acid 0.15%

Formulated for cats, dogs, and horses

Keep out of reach of children

For animal use only

NDC 11695-6989-1

Net contents: 8 fl oz (237 mL)

covetrus


Principal Display Panel - 16 Ounce (473 Ml) Bottle



Inspired by veterinarians

CeraSoothe SA

Otic Cleansing Solution

Fragrance: Cucumber melon

Salicylic Acid 0.15%

Formulated for cats, dogs, and horses

Keep out of reach of children

For animal use only

NDC 11695-6989-2

Net contents: 16 fl oz (473 mL)

covetrus


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