Label: DOUXO MICELLAR- phytosphingosine hydrochloride solution
- NDC Code(s): 13744-104-01, 13744-104-02
- Packager: Ceva Sante Animale
- 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 June 23, 2022
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DESCRIPTION
DOUXO®
Micellar Solution
Phytosphingosine HCL 0.02%
ACTIVE INGREDIENT: Phytosphingosine HCL 0.02%
INGREDIENTS: Water, Polysorbate 80, Alcohol Denatured, Propylene Glycol, Laureth-9, Poloxamer 184, Biosaccharide Gum-2, Imidazolidinyl Urea, Phenoxyethanol, Potassium Sorbate, Citric acid, Fragrance.
PROPERTIES: Douxo® Micellar Solution contains micellar technology and soothing agents help emulsify and wash out waxy debris without drying. The solution is non-greasy and non-staining. Douxo® Micellar Solution also contains Phytosphingosine, a Ceva exclusive pro-ceramide to help support a healthy skin barrier.
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INDICATIONS & USAGE
INDICATIONS: For use in dogs and cats only. For the cleaning of the ear canal, eye contours and skin folds. May be used go clean soiled and matted hair, or greasy skin associated with seborrheic conditions.
DIRECTIONS FOR USE: Shake well before use. For ear cleaning, ask your veterinarian which of the 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 upwards and fill the ear canal with solution.
Gently massage the base of the ear for 60 seconds. Remove the cotton ball (if used) and allow the pet to shake its head. Gently wipe away visible debris and excess solution with a clean, dry cotton ball.
To clean other areas of the skin, moisten a cotton ball or gauze with the solution and gently wipe the area to cleanse and remove visible debris. Repeat as often as necessary until clean.
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WARNINGS AND PRECAUTIONS
CAUTIONS: For external use on dogs and cats only. Avoid contact with the eyes. In case of contact with 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 AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 125 mL BOTTLE
- PRINCIPAL DISPLAY PANEL - 250 mL BOTTLE
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INGREDIENTS AND APPEARANCE
DOUXO MICELLAR
phytosphingosine hydrochloride solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:13744-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE .2 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:13744-104-01 125 mL in 1 BOTTLE, PLASTIC 2 NDC:13744-104-02 250 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/01/2015 Labeler - Ceva Sante Animale (261126049) Registrant - Ceva Sante Animale (261126049)