Animal NDC 11695-7223-6 Phyto S Otic Cleansing

Salicylic Acid, Phytosphingosine Hcl

Animal Product Information

Field Name Field Value
Animal NDC Code 11695-7223-6
Proprietary Name Phyto S Otic Cleansing 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, Phytosphingosine Hcl 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 dogs, cats, and horses only. For cleansing and/or drying the ear canal.Directions for use: Shake well before use. For ear cleaning, ask your veterinarian which of the two following protocols is best for your pet:Moisten a cotton ball with solution and place in the entrance of the ear canal; orHold 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.
Active Ingredient(s)
  • Salicylic Acid
  • Phytosphingosine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (0MBZ20845F)
  • NONOXYNOL-12 (6NR43D77O6)
  • GLYCERIN (PDC6A3C0OX)
  • BENZOIC ACID (8SKN0B0MIM)
  • BENZYL ALCOHOL (LKG8494WBH)
  • LACTIC ACID (33X04XA5AT)
  • EDETATE SODIUM (MP1J8420LU)
  • DI-N-OCTYL SODIUM SULFOSUCCINATE (4YLY5570Y0)
  • ALOE VERA LEAF (ZY81Z83H0X)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (0MBZ20845F)
  • NONOXYNOL-12 (6NR43D77O6)
  • GLYCERIN (PDC6A3C0OX)
  • BENZOIC ACID (8SKN0B0MIM)
  • BENZYL ALCOHOL (LKG8494WBH)
  • LACTIC ACID (33X04XA5AT)
  • EDETATE SODIUM (MP1J8420LU)
  • DI-N-OCTYL SODIUM SULFOSUCCINATE (4YLY5570Y0)
  • ALOE VERA LEAF (ZY81Z83H0X)
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.

Phyto S Otic Cleansing 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



Phyto S Otic Cleansing Solution

Active ingredients: Salicylic acid, 0.15%, phytosphingosine HCl 0.01%.

Inactive ingredients: Water, SDA 40B 190 proof, propylene glycol, disodium oleamido MIPA sulfosuccinate, nonoxynol-12, glycerin, fragrance, benzoic acid, benzyl alcohol, lactic acid, tetrasodium EDTA, sodium dioctyl sulfosuccinate, aloe barbadensis leaf juice.

Properties: Phyto S otic cleansing solution is formulated with salicylic acid, a beta-hydroxy acid (BHA) to exfoliate and penetrate dead skin cells and dirt to clean and deodorize the ear canal. It also contains phytosphingosine, a pro-ceramide to help moisturize and support a healthy skin barrier.


Indications & Usage



Indications: For use on dogs, cats, and horses only. For cleansing and/or drying the ear canal.

Directions for use: Shake well before use. For ear cleaning, ask your veterinarian which of the two following protocols is best for your pet:

  • Moisten a cotton ball with solution and place in the entrance of the ear canal; or
  • 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.


Warnings And Precautions



Cautions: For external use in dogs, cats, and horses only. Avoid contact with 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. Wash hands after use.


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 - 4 Fl Oz (118 Ml)



covetrus

NDC: 11695-7223-4

Phyto S

Salicylic acid 0.15%,

phytosphingosine HCl 0.01%

Otic Cleansing Solution

For cleansing and/or drying the ear canal in dogs, cats and horses

For animal use only

Keep out of reach of children

Net contents: 4 fl oz (118 mL)


Principal Display Panel - 8 Fl Oz (237 Ml)



covetrus

NDC: 11695-7223-8

Phyto S

Salicylic acid 0.15%,

phytosphingosine HCl 0.01%

Otic Cleansing Solution

For cleansing and/or drying the ear canal in dogs, cats and horses

For animal use only

Keep out of reach of children

Net contents: 8 fl oz (237 mL)


Principal Display Panel - 16 Ounce (473 Ml)



covetrus

NDC: 11695-7223-6

Phyto S

Salicylic acid 0.15%,

phytosphingosine HCl 0.01%

Otic Cleansing Solution

For cleansing and/or drying the ear canal in dogs, cats and horses

For animal use only

Keep out of reach of children

Net contents: 16 fl oz (473 mL)


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