OTI-SOOTHE PS EAR CLEANSING- salicylic acid, phytosphingosine hcl solution 
Ceva Sante Animale

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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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: Oti-Soothe® +PS Ear Cleansing Solution is specifically formulated to deodorize and gently clean, dry and acidify the ear canal. This provides an optimal environment to help maintain healthy ears. Oti-soothe® +PS also contains phytosphingosine, a CEVA exclusive pro-ceramide to help support a healthy skin barrier.

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

DIRECTIONS FOR USE: Apply liberally into the ear canal. Massage the base of the ear. Allow pet to shake head. Clean excess with a cotton ball. In excessively dirty ears, apply 2-3 times daily over several days. For maintenance of healthy ears, apply 1-2 times weekly or as directed by your veterinarian. Recommended after swimming to help dry ear canal.

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

WARNING: Keep out of the reach of children.

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

Authorized for sale through licensed veterinarians only.

Manufactured for Ceva Animal Health, LLC

Lenexa, KS 66215 ¦ 1-800-999-0297

©2015 Ceva Animal Health, LLC

PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle

OTI-SOOTHE® +PS

Ear Cleansing Solution

Salicylic Acid 0.15%, Phytosphingosine HCl 0.01%

Dogs • Cats

Phytosphingosine

Net Content: 4 FL. OZ. (118 mL)

Ceva

image description

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

OTI-SOOTHE® +PS

Ear Cleansing Solution

Salicylic Acid 0.15%, Phytosphingosine HCl 0.01%

Dogs • Cats

Phytosphingosine

Net Content: 8 FL. OZ. (237 mL)

Ceva

image description

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

OTI-SOOTHE® +PS

Ear Cleansing Solution

Salicylic Acid 0.15%, Phytosphingosine HCl 0.01%

Dogs • Cats

Phytosphingosine

Net Content: 16 FL. OZ. (473 mL)

Ceva

image description

OTI-SOOTHE PS EAR CLEANSING 
salicylic acid, phytosphingosine hcl solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13744-131
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:13744-131-01118 mL in 1 BOTTLE, PLASTIC
2NDC:13744-131-02237 mL in 1 BOTTLE, PLASTIC
3NDC:13744-131-03473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/201607/22/2019
Labeler - Ceva Sante Animale (261126049)
Registrant - Ceva Sante Animale (261126049)

Revised: 7/2019
 
Ceva Sante Animale