PHYTO S OTIC CLEANSING- salicylic acid, phytosphingosine hcl solution 
Butler Animal Health Supply, LLC dba Covetrus North America

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.

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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: 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:

  1. Moisten a cotton ball with solution and place in 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.

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: Store at room temperature. Do not freeze.

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)

4 ounce bottle label

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)

8 ounce bottle label

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)

16 ounce bottle label

PHYTO  S OTIC CLEANSING
salicylic acid, phytosphingosine hcl solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7223
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.5 mg  in 1 mL
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F)  
NONOXYNOL-12 (UNII: 6NR43D77O6)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
LACTIC ACID (UNII: 33X04XA5AT)  
EDETATE SODIUM (UNII: MP1J8420LU)  
DI-N-OCTYL SODIUM SULFOSUCCINATE (UNII: 4YLY5570Y0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-7223-4118 mL in 1 BOTTLE, PLASTIC
2NDC:11695-7223-8237 mL in 1 BOTTLE, PLASTIC
3NDC:11695-7223-6473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2020
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 12/2019
Document Id: 05071f75-cc58-494e-8031-96475ebfea6b
Set id: 16fd0f28-5923-4521-b624-f4353210be3b
Version: 1
Effective Time: 20191217
 
Butler Animal Health Supply, LLC dba Covetrus North America