Animal NDC 50386-1340-1 Skinguard Relieve

Pramoxine Hydrochloride, Phytosphingosine Salicyloyl

Animal Product Information

Field Name Field Value
Animal NDC Code 50386-1340-1
Proprietary Name Skinguard Relieve What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Pramoxine Hydrochloride, Phytosphingosine Salicyloyl What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Vicar Operating Inc.
Product Type Otc Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Pramoxine Hydrochloride
  • Salicyloyl Phytosphingosine
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • SODIUM C14-16 OLEFIN SULFONATE (O9W3D3YF5U)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • DISODIUM COCOAMPHODIACETATE (18L9G3U51M)
  • GLYCERIN (PDC6A3C0OX)
  • SODIUM LACTATE (TU7HW0W0QT)
  • HYPROMELLOSES (3NXW29V3WO)
  • EDETATE SODIUM (MP1J8420LU)
  • SODIUM CHLORIDE (451W47IQ8X)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • OATMEAL (8PI54V663Y)
  • SAFFLOWER OIL (65UEH262IS)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • WATER (059QF0KO0R)
  • SODIUM C14-16 OLEFIN SULFONATE (O9W3D3YF5U)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • DISODIUM COCOAMPHODIACETATE (18L9G3U51M)
  • GLYCERIN (PDC6A3C0OX)
  • SODIUM LACTATE (TU7HW0W0QT)
  • HYPROMELLOSES (3NXW29V3WO)
  • EDETATE SODIUM (MP1J8420LU)
  • SODIUM CHLORIDE (451W47IQ8X)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • OATMEAL (8PI54V663Y)
  • SAFFLOWER OIL (65UEH262IS)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Skinguard Relieve Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



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.


Indications & Usage



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.


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.

WARNING: Keep out of the reach of children.


Storage And Handling



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

Authorized for sale through licensed veterinarians only.


Other



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)


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.