Label: SKINGUARD CLEANSE RINSE- salicylic acid, phytosphingosine hydrochloride solution
- NDC Code(s): 50386-1400-1
- 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 April 26, 2021
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DESCRIPTION
SkinGuard® Cleanse Rinse
Medicated rinse gently cleans ears
CUCUMBER/MELON SCENT
ACTIVE INGREDIENTS: Salicylic Acid 0.15%, Phytosphingosine HCl 0.01%.
INACTIVE INGREDIENTS: Water, SDA 40B 190 Proof, Propylene Glycol, Disodium Oleamido MIPA Sulfosuccinate, Nonoxynol-12, Glycerin, Fragrance, Benzoic Acid, Benzyl Alcohol, Lactic Acid, Tetrasodium EDTA, Sodium Dioctyl Sulfosuccinate, Aloe Barbadensis Leaf Juice.
PROPERTIES: SkinGuard® Cleanse is specifically formulated to deodorize and gently clean, dry and acidify the ear canal. This provides an optimal environment to help maintain healthy ears. SkinGuard® Cleanse 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 cleansing and/or drying the ear canal.
DIRECTIONS FOR USE: Apply liberally into the ear canal. Massage the base of the ear. Allow pet to shake head. Clean excess with a cotton ball. In excessively dirty ears, apply 2-3 times daily over several days. For maintenance of healthy ears, apply 1-2 times weekly or as directed by your veterinarian. Recommended after swimming to help dry ear canal.
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WARNINGS AND PRECAUTIONS
CAUTIONS: For external use on dogs and cats only. Avoid contact with the eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Do not use in the case of a suspected ruptured eardrum.
WARNING: Keep out of the reach of children.
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle
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INGREDIENTS AND APPEARANCE
SKINGUARD CLEANSE RINSE
salicylic acid, phytosphingosine hydrochloride solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:50386-1400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1.5 mg in 1 mL PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F) NONOXYNOL-12 (UNII: 6NR43D77O6) GLYCERIN (UNII: PDC6A3C0OX) BENZOIC ACID (UNII: 8SKN0B0MIM) BENZYL ALCOHOL (UNII: LKG8494WBH) LACTIC ACID (UNII: 33X04XA5AT) DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5) DI-N-OCTYL SODIUM SULFOSUCCINATE (UNII: 4YLY5570Y0) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50386-1400-1 237 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/28/2017 Labeler - Vicar Operating Inc (052503799) Registrant - Ceva Sante Animale (261126049)
