Label: VETRASEB M- chlorhexidine gluconate, miconazole nitrate, phytosphingosine salicyloyl shampoo
- NDC Code(s): 13985-726-08, 13985-726-16
- Packager: MWI/VetOne
- 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 September 9, 2019
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DESCRIPTION
VetraSeb™ M SHAMPOO
ACTIVE INGREDIENTS: Chlorhexidine Gluconate 2%, Miconazole Nitrate 2%, Phytosphingosine salicyloyl 0.05%.
INACTIVE INGREDIENTS: Water, Lauramine Oxide, Cocamidopropyl Betaine, Decyl Glucoside, Polyacrylate-1 Crosspolymer, Lactic Acid, Acetic Acid, Fragrance, Methylchloroisothiazolinone, Methylisothiazoline, Sodium Hydroxide.
PROPERTIES: VetOne® VetraSebTM M Shampoo combines the unique properties of Phytosphingosine with antibacterial and antifungal agents for management of skin conditions.
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INDICATIONS & USAGE
INDICATIONS: For use on dogs and cats only. For the management of dermatological conditions associated with infections responsive to
Chlorhexidine Gluconate and Miconazole Nitrate.DIRECTIONS FOR USE: Shake well before use. Wet the animal with cool water and massage the shampoo first on the areas with skin abnormalities, then on the rest of the body. Leave the shampoo on for 10 minutes then rinse with cool water. Use 2-3 times per week until symptoms subside or as directed by your veterinarian.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle
- PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle
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INGREDIENTS AND APPEARANCE
VETRASEB M
chlorhexidine gluconate, miconazole nitrate, phytosphingosine salicyloyl shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:13985-726 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg in 1 mL MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg in 1 mL SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) LACTIC ACID (UNII: 33X04XA5AT) ACETIC ACID (UNII: Q40Q9N063P) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13985-726-08 237 mL in 1 BOTTLE, PLASTIC 2 NDC:13985-726-16 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2017 Labeler - MWI/VetOne (019926120) Registrant - Ceva Sante Animale (261126049) Establishment Name Address ID/FEI Business Operations Lab Express International 800875106 api manufacture Establishment Name Address ID/FEI Business Operations Evonik Nutrition and Care GmbH 314906476 api manufacture