Animal NDC 50386-1390-1 Skinguard Balance

Phytosphingosine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 50386-1390-1
Proprietary Name Skinguard Balance 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. Wet the animal with warm water and apply SkinGuard® Balance. 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 to 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)
  • Phytosphingosine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • SODIUM LAURETH SULFATE (BPV390UAP0)
  • SODIUM DECYLGLUCOSIDE HYDROXYPROPYLSULFONATE (B306V77S6R)
  • COCO GLUCOSIDE (ICS790225B)
  • COCONUT ALCOHOL (13F4MW8Y9K)
  • CYCLOMETHICONE 5 (0THT5PCI0R)
  • STEARETH-20 METHACRYLATE (A268NZ57NB)
  • TROLAMINE (9O3K93S3TK)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • POLYQUATERNIUM-10 (400 CPS AT 2%) (HB1401PQFS)
  • ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (EPA1872R1N)
  • PERFLUOROPOLYMETHYLISOPROPYL ETHER (X6324K3MBW)
  • METHYLPARABEN (A2I8C7HI9T)
  • POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (0L414VCS5Y)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • WATER (059QF0KO0R)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • SODIUM LAURETH SULFATE (BPV390UAP0)
  • SODIUM DECYLGLUCOSIDE HYDROXYPROPYLSULFONATE (B306V77S6R)
  • COCO GLUCOSIDE (ICS790225B)
  • COCONUT ALCOHOL (13F4MW8Y9K)
  • CYCLOMETHICONE 5 (0THT5PCI0R)
  • STEARETH-20 METHACRYLATE (A268NZ57NB)
  • TROLAMINE (9O3K93S3TK)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • POLYQUATERNIUM-10 (400 CPS AT 2%) (HB1401PQFS)
  • ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (EPA1872R1N)
  • PERFLUOROPOLYMETHYLISOPROPYL ETHER (X6324K3MBW)
  • METHYLPARABEN (A2I8C7HI9T)
  • POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (0L414VCS5Y)
  • 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 Balance 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 Shampoo

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

ACTIVE INGREDIENT: Phytosphingosine HCl 0.1%.

INACTIVE INGREDIENTS: Water, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Decyl Glucoside, Cyclopentasiloxane, Coco Glucoside, Coconut Alcohol, Acrylates/Steareth-20 Methacrylate Copolymer, Acrylates Copolymer, Triethanolamine, Polyquaternium-10, Phenoxyethanol, Polyperfluoromethylisopropyl Ether, Methylparaben, Fragrance, Polyquaternium-7, Methylchloroisothiazolinone, Methylisothiazolinone.

PROPERTIES:SkinGuard® Balance is a formulation designed to cleanse greasy and/or dry, scaly skin of dogs and cats. It is soap-free and contains moisturizers and film-forming agents to help maintain a normal production of sebum and skin cells. SkinGuard® Balance also contains phytosphingosine, a pro-ceramide to help soothe skin irritations and support a healthy skin barrier.


Indications & Usage



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

DIRECTIONS FOR USE: Shake well before use. Wet the animal with warm water and apply SkinGuard® Balance. 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 to 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



balance

Phytosphingosine HCl 0.1%

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

SkinGuard®

VETHICAL®

WITH PHYTOSPINGOSINE

8 FL OZ (237 mL)


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