Label: DOUXO CALM MOUSSE- phytosphingosine liquid
- NDC Code(s): 13744-125-01
- 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 7, 2016
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DESCRIPTION
DOUXO®
Calm Mousse
ACTIVE INGREDIENTS: Phytosphingosine HCL 0.05%.
INACTIVE INGREDIENTS: Water, Capryl/Capramidopropyl Betaine, Diethylhexyl Carbonate, Polyglyceryl-4 Laurate, Phenoxyethanol, Dilauryl Citrate, Glycerin, Spent Grain Wax, Butyrospermum Parkii (Shea Butter) Extract, Argania Spinosa Kernal Oil, Avena Sativa (Oat) Kernel Extract, Potassium Sorbate, Ceramide 3, Ceramide 6-II, Ceramide 1, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Butylene Glycol, Saccharomyces Cerevisiae Extract, Hydrogenated Polyisobutene, Ceteareth-20, Phenoxyethanol, Polyquaternium 51, Fragrance, Sodium Hydroxide.
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INDICATIONS & USAGE
INDICATIONS: For use on dogs and cats only. For the management of pruritus and inflammation associated with allergic conditions.
DIRECTIONS FOR USE: Shake well before use.
For localized application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the targeted area, massage into the skin until fully penetrated. Do not rinse. Let air dry. Once dry, brush the hair coat again.
For whole body application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the skin and hair. Massage into the skin until fully penetrated. Repeat as many times as necessary to cover the whole body, avoiding areas around the eyes and mouth. Do not rinse. Let air dry. Once dry, brush the hair coat again.
Dosage:
Under 11 lbs: 1 pump per 2 lbs
12-88 lbs: 1 pump per 4 lbs
Over 89 lbs: 1 pump per 6 lbs
Dosage can be doubled for long-haired breeds.
Apply every 3 days for 2 to 3 weeks or as recommended by your veterinarian. May be used as part of a management plan as recommended by your veterinarian.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 200 mL (6.8 OUNCE) BOTTLE
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INGREDIENTS AND APPEARANCE
DOUXO CALM MOUSSE
phytosphingosine liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:13744-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE .5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE) DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L) PHENOXYETHANOL (UNII: HIE492ZZ3T) DILAURYL CITRATE (UNII: 5OYS3G306B) GLYCERIN (UNII: PDC6A3C0OX) OAT (UNII: Z6J799EAJK) SHEA BUTTER (UNII: K49155WL9Y) ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CERAMIDE 3 (UNII: 4370DF050B) CERAMIDE 6 II (UNII: F1X8L2B00J) CERAMIDE 1 (UNII: 5THT33P7X7) CHOLESTEROL (UNII: 97C5T2UQ7J) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) CARBOMER 940 (UNII: 4Q93RCW27E) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13744-125-01 200 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2016 Labeler - Ceva Sante Animale (261126049) Registrant - Ceva Sante Animale (261126049)
