Label: SKINGUARD BALANCE MOUSSE- phytosphingosine hydrochloride liquid
- NDC Code(s): 50386-1380-1
- 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 November 16, 2017
If you are a consumer or patient please visit this version.
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DESCRIPTION
SkinGuard® Balance Mousse
Soap-free mousse helps restore the skin’s natural moisture balance and clear dryness and flakiness
ACTIVE INGREDIENT: Phytosphingosine HCl 0.2%
INACTIVE INGREDIENTS: Water, PEG/PPG/Polybutylene Glycol - 8/5/3 Glycerin, Glycerin, Panthenol, Sodium Lactate, Butylene Glycol, Capryl/Capramidopropyl Betaine, Polyglyceryl-10 Laurate, Dipropylene Glycol, Boswellia Serrata Gum Extract, Phenoxyethanol, Polyaminopropyl Biguanide, Fragrance.
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INDICATIONS & USAGE
INDICATIONS: For use on dogs and cats only. For the management of kerato-seborrheic conditions.
DIRECTIONS FOR USE: Shake well before use.
For localized application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the targeted area, massage into the skin until fully penetrated. Do not rinse. Let air dry. Once dry, brush the hair coat again.
For whole body application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the skin and hair. Massage into the skin until fully penetrated. Repeat as many times as necessary to cover the whole body, avoiding areas around the eyes and mouth. Do not rinse. Let air dry. Once dry, brush the hair coat again.
Dosage:
Under 11 lbs: 1 pump per 2 lbs
11-88 lbs: 1 pump per 4 lbs
Over 88 lbs: 1 pump per 6 lbs
Dosage can be doubled for long-haired breeds.
Apply every 3 days for 2 to 3 weeks or as recommended by your veterinarian. May be used in protocol with SkinGuard® Balance Shampoo, bathing on day 1 and applying the mousse on day 3 and day 6.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 200 mL (6.8 OUNCE) BOTTLE
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INGREDIENTS AND APPEARANCE
SKINGUARD BALANCE MOUSSE
phytosphingosine hydrochloride liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:50386-1380 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CAPRAMIDOPROPYL BETAINE (UNII: IQ93EE887Z) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PPG-3 (UNII: 3C8845E7C1) GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) SODIUM LACTATE (UNII: TU7HW0W0QT) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G) DIPROPYLENE GLYCOL (UNII: E107L85C40) BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50386-1380-1 200 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/16/2017 Labeler - Vicar Operating Inc. (052503799) Registrant - Ceva Sante Animale (261126049)
