KeraSeb: Product Information

KERASEB- salicylic acid shampoo
GlenHaven LLC

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.

KeraSeb Shampoo is an antiseborrheic shampoo designed to soften and remove scales and crusts associated with seborrhea. Ceramides aid in moisturizing, repairing, and restoring dry, damaged skin.

CONTAINS: 2% solubilized sulfur, 2% salicylic acid, ceramides, cocamidopropyl betaine, coconut oil.

DIRECTIONS: Shake well before using. Apply to wet coat, rub onto skin and haircoat until lightly lathered. Allow shampoo to remain on skin and coat for 5-10 minutes. Rinse well. Use 2-3 times per week or as directed by veterinarian.

CAUTION: For topical use only. Avoid contact with eyes. If skin irritation develops or increases, stop use and call your veterinarian. Do not use on severely irritated skin. Keep out of the reach of children and pets. Wash hands after use.

STORAGE: Store at controlled room temperature of 59°- 86° F (15°- 30° C).

Available through licensed veterinarians only.

Manufactured for:

GlenHaven
PO Box 13998
8000 NE Tillamook St.
Portland, OR 97213

PRINCIPAL DISPLAY PANEL — 355 mL Bottle Label

GlenHaven™ Therapeutics

Medically Formulated

KeraSeb Shampoo

New Improved Formulation
Formerly S/S

For dry seborrhea

Solubilized sulfur, salicylic acid

For Dog and Cat Use Only

Net Contents: 12 FL OZ. (355 mL)

KERASEB salicylic acid shampoo

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:70782-300 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (Salicylic Acid) Salicylic Acid 20 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER SODIUM C14-16 OLEFIN SULFONATE COCAMIDOPROPYL BETAINE SODIUM THIOSULFATE Sodium Chloride GLYCERIN Disodium Cocoamphodiacetate HYPROMELLOSE, UNSPECIFIED EDETATE SODIUM CERAMIDE NP CERAMIDE AP CERAMIDE 1 PHYTOSPHINGOSINE CHOLESTEROL SODIUM LAUROYL LACTYLATE CARBOXYPOLYMETHYLENE XANTHAN GUM COCONUT OIL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70782-300-12 355 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 06/01/2016

Labeler — GlenHaven LLC (002542300)

Registrant — Dechra Veterinary Products (362142734)

Revised: 09/2017 GlenHaven LLC