Label: MICELLAR OTIC CLEANSER- phytosphingosine salicyloyl solution
- NDC Code(s): 11695-6988-1, 11695-6988-2
- 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 May 23, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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DESCRIPTION
Micellar Otic Cleanser
Phytosphingosine Salicyloyl 0.05%
A non-greasy formula that cleans and deodorizes the ear canal. Contains micellar technology to help emulsify and wash out waxy debris without drying the skin. It also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.
Active Ingredient: Phytosphingosine Salicyloyl 0.05%
Inactive Ingredients: Water, polysorbate 80, SD alcohol 40-B, propylene glycol, laureth-9, poloxamer 184, imidazolidinyl urea, phenoxyethanol, potassium sorbate, biosaccharide gum-2, citric acid, fragrance.
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INDICATIONS & USAGE
Indications: For use in cats, dogs, and horses to gently cleanse the ear canal or other areas of the skin.
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 in the entrance of the ear canal; OR
2) Hold the 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. Wash hands after use.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 125 mL BOTTLE
- PRINCIPAL DISPLAY PANEL - 250 mL BOTTLE
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INGREDIENTS AND APPEARANCE
MICELLAR OTIC CLEANSER
phytosphingosine salicyloyl solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-6988 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) SALICYLOYL PHYTOSPHINGOSINE .5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LAURETH-9 PHOSPHATE (UNII: 0N8G76HI1O) POLOXAMER 184 (UNII: BIS92ZSF57) BIOSACCHARIDE GUM-2 (UNII: UVQ34I5XKQ) IMIDUREA (UNII: M629807ATL) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-6988-1 125 mL in 1 BOTTLE, PLASTIC 2 NDC:11695-6988-2 250 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/16/2021 Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329) Registrant - Ceva Sante Animale (261126049)
