Label: SKINGUARD RELIEVE- pramoxine hydrochloride, phytosphingosine salicyloyl shampoo
- NDC Code(s): 50386-1340-1
- Packager: Vicar Operating Inc.
- 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 December 6, 2017
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DESCRIPTION
SkinGuard® Relieve Shampoo
Soap-free shampoo that calms irritated skin and relieves itchiness
ACTIVE INGREDIENTS: Pramoxine HCl 1%, Phytosphingosine Salicyloyl 0.05%.
INACTIVE INGREDIENTS: Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Glycerin, Sodium Lactate, Hydroxypropyl Methylcellulose, Tetrasodium EDTA, Fragrance, Hydrolyzed Oat Protein, Carthamus inctorius (Safflower) Seed Oil, Citric Acid, Sodium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone.
PROPERTIES: SkinGuard® Relieve is a pleasantly scented formulation designed for the temporary relief of itching in dogs and cats. It is soap-free and contains mild cleansing bases. SkinGuard® Relieve contains pramoxine, a mild numbing agent, as well as colloidal oatmeal and essential fatty acids to further soothe irritated skin. SkinGuard® Relieve also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.
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INDICATIONS & USAGE
INDICATION: For use on dogs and cats only. For the temporary relief of pruritus and skin irritations.
DIRECTIONS FOR USE: Shake well before use. Wet the animal with warm water and apply SkinGuard® Relieve. Massage into the wet hair coat. Allow to remain on the hair coat for 5 to 10 minutes before rinsing thoroughly with clean water. Repeat if needed. Shampoo 2-3 times per week, for 1 to 2 weeks, or as directed 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 - 8 OUNCE (237 mL) Bottle
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INGREDIENTS AND APPEARANCE
SKINGUARD RELIEVE
pramoxine hydrochloride, phytosphingosine salicyloyl shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:50386-1340 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) SALICYLOYL PHYTOSPHINGOSINE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LACTATE (UNII: TU7HW0W0QT) HYPROMELLOSES (UNII: 3NXW29V3WO) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) OATMEAL (UNII: 8PI54V663Y) SAFFLOWER OIL (UNII: 65UEH262IS) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50386-1340-1 237 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/06/2017 Labeler - Vicar Operating Inc. (052503799) Registrant - Ceva Sante Animale (261126049)
