Label: DOUXO MICELLAR- phytosphingosine salicyloyl solution
- NDC Code(s): 13744-158-01, 13744-158-02
- 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 March 4, 2021
If you are a consumer or patient please visit this version.
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DESCRIPTION
DOUXO®
Micellar Solution
Phytosphingosine Salicyloyl 0.05%
ACTIVE INGREDIENT: Phytosphingosine Salicyloyl 0.05%
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.
PROPERTIES: Douxo® Micellar Solution contains micellar technology and soothing agents help emulsify and wash out waxy debris without drying the skin. The solution is non-greasy and non-staining. Douxo® Micellar Solution also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.
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INDICATIONS & USAGE
INDICATIONS: For use in dogs and cats for cleaning of the ear canal, eye contours and skin folds. May be used go clean soiled and matted hair, or greasy skin.
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.
Then 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 absorbent material with solution and gently wipe the area to cleanse and remove debris. Repeat as necessary until clean.
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WARNINGS AND PRECAUTIONS
CAUTIONS: For external use only; avoid contact with the eyes. If eye contact occurs, rinse thoroughly and consult with 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 salicyloyl solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:13744-158 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:13744-158-01 125 mL in 1 BOTTLE, PLASTIC 2 NDC:13744-158-02 250 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/05/2021 Labeler - Ceva Sante Animale (261126049) Registrant - Ceva Sante Animale (261126049)
