SkinGuard Clear: Product Information

SKINGUARD CLEAR- benzoyl peroxide, sodium thiosulfate, salicylic acid and phytosphingosine hydrochloride 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® Clear Shampoo

Soap-free medicated shampoo with antimicrobial properties helps treat oily, greasy and flaky skin

ACTIVE INGREDIENTS: Benzoyl Peroxide 3%, Salicylic Acid 2%, Precipitated Sulfur 2%, Phytosphingosine HCl 0.05%.

INACTIVE INGREDIENTS: Water, Sodium C14-16 Olefin Sulfonate, Propylene Glycol, Acrylates Copolymer, Myristamine Oxide, Fragrance, Tocopheryl Acetate, Sodium Dioctyl Sulfosuccinate, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Hydroxide.

PROPERTIES: SkinGuard® Clear is a cleansing, degreasing, soap-free shampoo for greasy seborrhea and hair follicle conditions. The combination of benzoyl peroxide, precipitated sulfur, and salicylic acid helps remove excessive oil, scales, and crust. SkinGuard® Clear also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS: For use on dogs and cats only. For the management of seborrheic disorders and skin infections.

DIRECTIONS FOR USE: Bathe 1-2 times per week for 2-3 weeks, or as directed by your veterinarian. Wet the animal with cool water from the neck down and apply shampoo first on the skin abnormalities. Starting with a quarter-size amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Leave shampoo on for 10 minutes before rinsing with cool water until the water runs clear.

CAUTIONS: For external use only, avoid contact with the eyes. If eye contact occurs, 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

PRINCIPAL DISPLAY PANEL — 8 OUNCE (237 mL) Bottle

clear

Benzoyl Peroxide 3%, Salicylic Acid 2%,

Precipitated Sulfur 2%, Phytosphingosine HCl 0.05%

Soap-free medicated shampoo with antimicrobial properties helps treat oily, greasy and flaky skin

VETHICAL®

SkinGuard®

WITH PHYTOSPHINGOSINE

8 FL. OZ. (237 mL)

8 ounce bottle label front
(click image for full-size original)
8 ounce bottle label front
(click image for full-size original)
8 ounce bottle label back
(click image for full-size original)
8 ounce bottle label front
(click image for full-size original)
8 ounce bottle label back
(click image for full-size original)
SKINGUARD CLEAR
benzoyl peroxide, precipitated sulfur, salicylic acid, phytosphingosine hydrochloride shampoo
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:50386-1411
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 30 mg in 1 mL
SODIUM THIOSULFATE (THIOSULFATE ION) SODIUM THIOSULFATE 20 mg in 1 mL
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 20 mg in 1 mL
PHYTOSPHINGOSINE HYDROCHLORIDE (PHYTOSPHINGOSINE) PHYTOSPHINGOSINE HYDROCHLORIDE 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM C14-16 OLEFIN SULFONATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (4500 MPA.S)
PROPYLENE GLYCOL
MYRISTAMINE OXIDE
DI-N-OCTYL SODIUM SULFOSUCCINATE
.ALPHA.-TOCOPHEROL ACETATE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50386-1411-1 237 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/27/2018
Labeler — VICAR OPERATING INC (052503799)
Registrant — Ceva Sante Animale (261126049)
Establishment
Name Address ID/FEI Operations
Vantage Specialty Ingredients, Inc. 117509092 api manufacture
Establishment
Name Address ID/FEI Operations
Evonik Operations GmbH 343170605 api manufacture

Revised: 04/2021 VICAR OPERATING INC

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