Label: SKINGUARD RELIEVE MOUSSE- pramoxine hydrochloride, phytosphingosine salicyloyl liquid
- NDC Code(s): 50386-1420-1
- 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 4, 2017
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DESCRIPTION
SkinGuard® Relieve Mousse
Soap-free mousse that calms irritated skin and relieves itchiness
ACTIVE INGREDIENT: Pramoxine HCl 1%, Phytosphingosine Salicyloyl 0.05%.
INACTIVE INGREDIENTS: Water, Glycerin, PEG-8 Dimethicone, Polysorbate 80, Poloxamer 184, Sodium Lactate, Hydrolyzed Oat Protein, Fragrance, Aloe Barbadensis (Aloe) Leaf Extract, Methylisothiazolinone.
PROPERTIES:SkinGuard® Relieve is a formulation designed for the temporary relief of itching in dogs and cats without bathing. It is soap-free, alcohol-free and moisturizing. SkinGuard® Relieve also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.
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INDICATIONS & USAGE
INDICATIONS: For use on dogs and cats only. For the temporary relief of pruritus and skin irritations.
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 may be doubled for long-haired breeds.Apply every 3 days for 2 to 3 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 - 6.8 OUNCE (200 mL) Bottle
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INGREDIENTS AND APPEARANCE
SKINGUARD RELIEVE MOUSSE
pramoxine hydrochloride, phytosphingosine salicyloyl liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:50386-1420 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) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PEG-8 DIMETHICONE (UNII: GIA7T764OD) SODIUM LACTATE (UNII: TU7HW0W0QT) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLOXAMER 184 (UNII: BIS92ZSF57) OAT (UNII: Z6J799EAJK) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50386-1420-1 200 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/04/2017 Labeler - Vicar Operating Inc (052503799) Registrant - Ceva Sante Animale (261126049)
