Animal NDC 50386-1370-1 Skinguard Restore

Chlorhexidine Gluconate, Climbazole, Phytosphingosine Salicyloyl

Animal Product Information

Field Name Field Value
Animal NDC Code 50386-1370-1
Proprietary Name Skinguard Restore 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 Chlorhexidine Gluconate, Climbazole, 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
    INDICATIONS: For use on dogs and cats only. For the management of skin infections that are responsive to chlorhexidine and climbazole.DIRECTIONS FOR USE: Wet the animal with warm water and apply SkinGuard® Restore. 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)
  • Climbazole
  • Chlorhexidine Gluconate
  • Salicyloyl Phytosphingosine
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • COCAMIDOPROPYL HYDROXYSULTAINE (62V75NI93W)
  • DECYL GLUCOSIDE (Z17H97EA6Y)
  • CAPRYLOYL GLYCINE (8TY5YO42NJ)
  • PEG-120 METHYL GLUCOSE DIOLEATE (YM0K64F20V)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • TROLAMINE (9O3K93S3TK)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • SODIUM HYDROXIDE (55X04QC32I)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • WATER (059QF0KO0R)
  • COCAMIDOPROPYL HYDROXYSULTAINE (62V75NI93W)
  • DECYL GLUCOSIDE (Z17H97EA6Y)
  • CAPRYLOYL GLYCINE (8TY5YO42NJ)
  • PEG-120 METHYL GLUCOSE DIOLEATE (YM0K64F20V)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • TROLAMINE (9O3K93S3TK)
  • PHENOXYETHANOL (HIE492ZZ3T)
  • SODIUM HYDROXIDE (55X04QC32I)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
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 Restore 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® Restore Shampoo

ACTIVE INGREDIENTS: Chlorhexidine Gluconate 3%, Climbazole 0.5%, Phytosphingosine Salicyloyl 0.05%.

INACTIVE INGREDIENTS: Water, Cocamidopropyl Hydroxysultaine, Decyl Glucoside, Capryloyl Glycine, PEG-120 Methyl Glucose Dioleate, Propylene Glycol, Triethanolamine, Phenoxyethanol, Sodium Hydroxide, Fragrance, Citric Acid.

PROPERTIES:SkinGuard® Restore is a formulation designed for the antiseptic cleansing of the skin of dogs and cats. It is soap-free and contains mild cleansing bases and moisturizers. SkinGuard® Restore 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 skin infections that are responsive to chlorhexidine and climbazole.

DIRECTIONS FOR USE: Wet the animal with warm water and apply SkinGuard® Restore. 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



Restore

CHLORHEXIDINE GLUCONATE 3%, CLIMBAZOLE 0.5%,
PHYTOSPHINGOSINE SALICYLOYL 0.05%

Soap-free shampoo with
anti-bacterial and anti-fungal
properties

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.