SkinGuard Relieve: Product Information

SKINGUARD RELIEVE- pramoxine hydrochloride and salicyloyl phytosphingosine shampoo
Vicar Operating Inc.

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.

SkinGuard® Relieve Shampoo

Soap-free shampoo that calms irritated skin and relieves itchiness

ACTIVE INGREDIENTS: Pramoxine HCl 1%, Phytosphingosine Salicyloyl 0.05%.

INACTIVE INGREDIENTS: Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Glycerin, Sodium Lactate, Hydroxypropyl Methylcellulose, Tetrasodium EDTA, Fragrance, Hydrolyzed Oat Protein, Carthamus inctorius (Safflower) Seed Oil, Citric Acid, Sodium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone.

PROPERTIES: SkinGuard® Relieve is a pleasantly scented formulation designed for the temporary relief of itching in dogs and cats. It is soap-free and contains mild cleansing bases. SkinGuard® Relieve contains pramoxine, a mild numbing agent, as well as colloidal oatmeal and essential fatty acids to further soothe irritated skin. SkinGuard® Relieve also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATION: For use on dogs and cats only. For the temporary relief of pruritus and skin irritations.

DIRECTIONS FOR USE: Shake well before use. Wet the animal with warm water and apply SkinGuard® Relieve. 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 2-3 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.

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.

WARNING: Keep out of the reach of children.

STORAGE CONDITIONS: Store at room temperature. Do not freeze.

Authorized for sale through licensed veterinarians only.

Distributed by Vicar Operating, Inc.

Los Angeles, CA 90064

Manufactured for Ceva Animal Health, LLC

Lenexa, KS 66215

Questions? Call us at 1-800-999-0297

PRINCIPAL DISPLAY PANEL — 8 OUNCE (237 mL) Bottle

relieve

PRAMOXINE HCl 1%, PHYTOSPHINGOSINE SALICYLOYL 0.05%

Soap-free shampoo that calms irritated skin and relieves itchiness

VETHICAL®

SkinGuard®

WITH PHYTOSPHINGOSINE

8 FL. OZ. (237 mL)

8 ounce bottle label front panel
(click image for full-size original)
8 ounce bottle label back panel
(click image for full-size original)
SKINGUARD RELIEVE
pramoxine hydrochloride, phytosphingosine salicyloyl shampoo
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:50386-1340
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL
SALICYLOYL PHYTOSPHINGOSINE (PHYTOSPHINGOSINE) SALICYLOYL PHYTOSPHINGOSINE 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM C14-16 OLEFIN SULFONATE
COCAMIDOPROPYL BETAINE
DISODIUM COCOAMPHODIACETATE
GLYCERIN
SODIUM LACTATE
HYPROMELLOSES
EDETATE SODIUM
SODIUM CHLORIDE
CITRIC ACID MONOHYDRATE
OATMEAL
SAFFLOWER OIL
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50386-1340-1 237 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/06/2017
Labeler — Vicar Operating Inc. (052503799)
Registrant — Ceva Sante Animale (261126049)

Revised: 12/2017 Vicar Operating Inc.

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