Label: SKINGUARD RESTORE- chlorhexidine gluconate, climbazole, phytosphingosine salicyloyl shampoo
- NDC Code(s): 50386-1370-1
- 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 20, 2017
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DESCRIPTION
SkinGuard® Restore Shampoo
ACTIVE INGREDIENTS: Chlorhexidine Gluconate 3%, Climbazole 0.5%, Phytosphingosine Salicyloyl 0.05%.
INACTIVE INGREDIENTS: Water, Cocamidopropyl Hydroxysultaine, Decyl Glucoside, Capryloyl Glycine, PEG-120 Methyl Glucose Dioleate, Propylene Glycol, Triethanolamine, Phenoxyethanol, Sodium Hydroxide, Fragrance, Citric Acid.
PROPERTIES:SkinGuard® Restore is a formulation designed for the antiseptic cleansing of the skin of dogs and cats. It is soap-free and contains mild cleansing bases and moisturizers. SkinGuard® Restore also contains phytosphingosine, a pro-ceramide to help soothe skin irritations and support a healthy skin barrier.
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INDICATIONS & USAGE
INDICATIONS: For use on dogs and cats only. For the management of skin infections that are responsive to chlorhexidine and climbazole.
DIRECTIONS FOR USE: Wet the animal with warm water and apply SkinGuard® Restore. 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 to 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 RESTORE
chlorhexidine gluconate, climbazole, phytosphingosine salicyloyl shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:50386-1370 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 30 mg in 1 mL CLIMBAZOLE (UNII: 9N42CW7I54) (CLIMBAZOLE - UNII:9N42CW7I54) CLIMBAZOLE 5 mg in 1 mL SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) SALICYLOYL PHYTOSPHINGOSINE .5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50386-1370-1 237 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/20/2017 Labeler - Vicar Operating Inc. (052503799) Registrant - Ceva Sante Animale (261126049)
