Label: DOUXO S3 PYO- ophytrium, chlorhexidine shampoo
- NDC Code(s): 13744-154-01, 13744-154-02
- 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 November 5, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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DESCRIPTION
PROPERTIES: Chlorhexidine provides antiseptic cleansing and 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 bacterial or fungal skin infections. Antiseptic shampoo that cleanses while hydrating the skin. Detangles the fur and leaves the coat soft and shiny.
DIRECTIONS: Use one pump for every 4 lbs. Double the dosage for long and/or thick fur. Wet with cool water from the neck down. First, gently massage shampoo onto the problem area. Repeat on entire body and leave on for 5-10 minutes before rinsing. Repeat if necessary. Wash hands after use. Use DOUXO® S3 PYO Mousse for a leave-on solution.
- PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 200 mL Bottle
- PRINCIPAL DISPLAY PANEL - 200 mL Bottle
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INGREDIENTS AND APPEARANCE
DOUXO S3 PYO
ophytrium, chlorhexidine shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:13744-154 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 5.0 mg in 1 mL CHLORHEXIDINE (UNII: R4KO0DY52L) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) SACCHARIDE ISOMERATE (UNII: W8K377W98I) PEG-200 GLYCERYL STEARATE (UNII: Z8ROG2A0LZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13744-154-01 200 mL in 1 BOTTLE, PLASTIC 2 NDC:13744-154-02 500 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)
