Label: DOUXO S3 SEB- ophytrium shampoo
- NDC Code(s): 13744-156-01, 13744-156-02
- 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 24, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: Water, cocomidopropyl hydroxysultaine, glycerine, sodium methyl lauroyl isethionate, sodium methyl cocoyl taurate, disodium laureth sulfosuccinate, caprylamidopropyl betaine/capramidopropyl betaine, seboliance™ (punica granatum extract),
pentavitin® (saccharide isomerate), panthenol, niacinamide (vit. PP), coco + vanilla hypoallergenic fragrance, glycol distearate, phenoxyethanol, guar gum, sodium benzoate, butylene glycol, acrylates/C10-30 alkyl acrylate, disodium EDTA, citric acid, sodium hydroxide. -
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 -
INDICATIONS & USAGE
INDICATIONS: For use on dogs or cats with oily or flaky skin. Helps control dandruff and odor by normalizing sebum production 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. Use DOUXO® S3 SEB Mousse for a leave-on solution.
- PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 200 mL Bottle
- PRINCIPAL DISPLAY PANEL - 500 mL Bottle
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INGREDIENTS AND APPEARANCE
DOUXO S3 SEB
ophytrium shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:13744-156 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 Inactive Ingredients Ingredient Name Strength COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) GLYCERIN (UNII: PDC6A3C0OX) CAPRAMIDOPROPYL BETAINE (UNII: IQ93EE887Z) CAPRYLAMIDOPROPYL BETAINE (UNII: 26JA650O77) PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6) SACCHARIDE ISOMERATE (UNII: W8K377W98I) NIACINAMIDE (UNII: 25X51I8RD4) GLYCOL DISTEARATE (UNII: 13W7MDN21W) PHENOXYETHANOL (UNII: HIE492ZZ3T) GUAR GUM (UNII: E89I1637KE) SODIUM BENZOATE (UNII: OJ245FE5EU) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) EDETATE DISODIUM (UNII: 7FLD91C86K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13744-156-01 200 mL in 1 BOTTLE, PLASTIC 2 NDC:13744-156-02 500 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)
