Animal NDC 50386-1380-1 Skinguard Balance Mousse

Phytosphingosine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 50386-1380-1
Proprietary Name Skinguard Balance Mousse 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 Phytosphingosine Hydrochloride 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
    INDICATIONS: For use on dogs and cats only. For the management of kerato-seborrheic conditions. 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 lbs11-88 lbs: 1 pump per 4 lbsOver 88 lbs: 1 pump per 6 lbsDosage can be doubled for long-haired breeds.Apply every 3 days for 2 to 3 weeks or as recommended by your veterinarian. May be used in protocol with SkinGuard® Balance Shampoo, bathing on day 1 and applying the mousse on day 3 and day 6.
Active Ingredient(s)
  • Phytosphingosine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • CAPRAMIDOPROPYL BETAINE (IQ93EE887Z)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (3WJQ0SDW1A)
  • PPG-3 (3C8845E7C1)
  • GLYCERIN (PDC6A3C0OX)
  • PANTHENOL (WV9CM0O67Z)
  • SODIUM LACTATE (TU7HW0W0QT)
  • BUTYLENE GLYCOL (3XUS85K0RA)
  • POLYGLYCERYL-10 LAURATE (MPJ2Q8WI8G)
  • DIPROPYLENE GLYCOL (E107L85C40)
  • BOSWELLIA SERRATA RESIN OIL (5T1XCE6K8K)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • POLYAMINOPROPYL BIGUANIDE (322U039GMF)
  • WATER (059QF0KO0R)
  • CAPRAMIDOPROPYL BETAINE (IQ93EE887Z)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (3WJQ0SDW1A)
  • PPG-3 (3C8845E7C1)
  • GLYCERIN (PDC6A3C0OX)
  • PANTHENOL (WV9CM0O67Z)
  • SODIUM LACTATE (TU7HW0W0QT)
  • BUTYLENE GLYCOL (3XUS85K0RA)
  • POLYGLYCERYL-10 LAURATE (MPJ2Q8WI8G)
  • DIPROPYLENE GLYCOL (E107L85C40)
  • BOSWELLIA SERRATA RESIN OIL (5T1XCE6K8K)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • POLYAMINOPROPYL BIGUANIDE (322U039GMF)
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 Balance Mousse Images

Skinguard Balance Mousse 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® Balance Mousse

Soap-free mousse helps restore the skin’s natural moisture balance and clear dryness and flakiness

ACTIVE INGREDIENT: Phytosphingosine HCl 0.2%

INACTIVE INGREDIENTS: Water, PEG/PPG/Polybutylene Glycol - 8/5/3 Glycerin, Glycerin, Panthenol, Sodium Lactate, Butylene Glycol, Capryl/Capramidopropyl Betaine, Polyglyceryl-10 Laurate, Dipropylene Glycol, Boswellia Serrata Gum Extract, Phenoxyethanol, Polyaminopropyl Biguanide, Fragrance.


Indications & Usage



INDICATIONS: For use on dogs and cats only. For the management of kerato-seborrheic conditions. 

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 can be doubled for long-haired breeds.

Apply every 3 days for 2 to 3 weeks or as recommended by your veterinarian. May be used in protocol with SkinGuard® Balance Shampoo, bathing on day 1 and applying the mousse on day 3 and day 6.


Warnings And Precautions



CAUTIONS: For external use on dogs and cats only. Avoid contact with the eyes. If contact with the eyes occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult 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 - 200 Ml (6.8 Ounce) Bottle



balance

PHYTOSPHINGOSINE HCl 0.2%

Soap-free mousse helps
restore the skin’s natural
moisture balance and clear
dryness and flakiness

VETHICAL®

SkinGuard®

WITH PHYTOSPHINGOSINE

200 ml (6.8 fl. oz.)


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