Label: PHYTO S OTIC CLEANSING- salicylic acid, phytosphingosine hcl solution
- NDC Code(s): 11695-7223-4, 11695-7223-6, 11695-7223-8
- Packager: Butler Animal Health Supply, LLC dba Covetrus North America
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated December 17, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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.
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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.
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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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 fl oz (118 mL)
- PRINCIPAL DISPLAY PANEL - 8 fl oz (237 mL)
- PRINCIPAL DISPLAY PANEL - 16 ounce (473 mL)
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INGREDIENTS AND APPEARANCE
PHYTO S OTIC CLEANSING
salicylic acid, phytosphingosine hcl solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-7223 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1.5 mg in 1 mL PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-7223-4 118 mL in 1 BOTTLE, PLASTIC 2 NDC:11695-7223-8 237 mL in 1 BOTTLE, PLASTIC 3 NDC:11695-7223-6 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2020 Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329) Registrant - Ceva Sante Animale (261126049)
