Label: DOUXO S3 CALM MOUSSE- ophytrium liquid
- NDC Code(s): 13744-150-01
- 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 November 24, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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DESCRIPTION
PROPERTIES: Ophytrium is a purified, natural ingredient from the S3 - Safe Skincare Selection. Ophytrium has been carefully selected for its high tolerance and simultaneous threefold action on the skin’s ecosystem: • Helps support the skin's physical barrier for supple, hydrated skin • Helps support the microbial flora for healthy skin • Helps soothe irritated skin
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INDICATIONS & USAGE
INDICATIONS: For use on dogs or cats with itchy, irritated or allergic skin. Helps soothe while hydrating the skin. Detangles the fur and leaves the coat soft and shiny.
DIRECTIONS: Apply to a brushed, dry coat. First, gently massage onto the problem area until the mousse reaches the skin. Repeat this action all over the body, avoiding the eyes and mouth. Let air dry. Brush for a shiny coat. Wash hands after use. Use DOUXO® S3 CALM Shampoo to clean the skin if needed.
- PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 200 mL Bottle
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INGREDIENTS AND APPEARANCE
DOUXO S3 CALM MOUSSE
ophytrium liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:13744-150 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ) (OPHIOPOGON JAPONICUS ROOT - UNII:90PS6JV9GZ) OPHIOPOGON JAPONICUS ROOT 7.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SACCHARIDE ISOMERATE (UNII: W8K377W98I) PANTHENOL (UNII: WV9CM0O67Z) NIACINAMIDE (UNII: 25X51I8RD4) GUAR GUM (UNII: E89I1637KE) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13744-150-01 150 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/25/2020 Labeler - Ceva Sante Animale (261126049) Registrant - Ceva Sante Animale (261126049)