Label: SKINGUARD BALANCE- phytosphingosine hydrochloride shampoo
- NDC Code(s): 50386-1390-1
- 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 30, 2017
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DESCRIPTION
SkinGuard® Balance Shampoo
Soap-free shampoo helps restore the skin’s natural moisture balance and clear dryness and flakiness
ACTIVE INGREDIENT: Phytosphingosine HCl 0.1%.
INACTIVE INGREDIENTS: Water, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Decyl Glucoside, Cyclopentasiloxane, Coco Glucoside, Coconut Alcohol, Acrylates/Steareth-20 Methacrylate Copolymer, Acrylates Copolymer, Triethanolamine, Polyquaternium-10, Phenoxyethanol, Polyperfluoromethylisopropyl Ether, Methylparaben, Fragrance, Polyquaternium-7, Methylchloroisothiazolinone, Methylisothiazolinone.
PROPERTIES:SkinGuard® Balance is a formulation designed to cleanse greasy and/or dry, scaly skin of dogs and cats. It is soap-free and contains moisturizers and film-forming agents to help maintain a normal production of sebum and skin cells. SkinGuard® Balance 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 kerato-seborrheic conditions.
DIRECTIONS FOR USE: Shake well before use. Wet the animal with warm water and apply SkinGuard® Balance. 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 BALANCE
phytosphingosine hydrochloride shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:50386-1390 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM DECYLGLUCOSIDE HYDROXYPROPYLSULFONATE (UNII: B306V77S6R) COCO GLUCOSIDE (UNII: ICS790225B) COCONUT ALCOHOL (UNII: 13F4MW8Y9K) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) STEARETH-20 METHACRYLATE (UNII: A268NZ57NB) TROLAMINE (UNII: 9O3K93S3TK) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS) ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N) PERFLUOROPOLYMETHYLISOPROPYL ETHER (UNII: X6324K3MBW) METHYLPARABEN (UNII: A2I8C7HI9T) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50386-1390-1 237 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/30/2017 Labeler - Vicar Operating Inc. (052503799) Registrant - Ceva Sante Animale (261126049)
