KERATOLUX- piroctone olamine shampoo

Keratolux by

Drug Labeling and Warnings

Keratolux by is a Animal medication manufactured, distributed, or labeled by Virbac AH, Inc., Virbac Corporation, Kumar Organic Products Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

USE IN SPECIFIC POPULATIONS

USES: KERATOLUX® Shampoo with S-I-S SKIN INNOVATIVE SCIENCE® Technology is a unique cleanser that removes scales,  crusts, and excess oil on the skin surface of dogs and cats. With regular bathing, KERATOLUX Shampoo helps manage normal sebum production, resulting in a pleasant smell and healthy appearance to the skin and coat.

• Improve hair coat and skin balance:

        ◊ Removes excess sebum and scales          ◊ neutralizes unpleasant odors

• Support healthy skin with S-I-S SKIN INNOVATIVE SCIENCE Technology:

         ◊ Provides micro-organism anti-adhesive effects (Glycotechnology)
         ◊ Promotes natural skin microbial defenses (Defensin technology)

• Promote a healthy microbial balance in animals with keratoseborrheic conditions (Piroctone Olamine)

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: Piroctone Olamine 0.5% w/w

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Alkylpolyglucoside, Butylene Glycol, Coco-Betaine, d-Galactose, d-Mannose, Disodium EDTA, Glycerin, l-Rhamnose, Laureth-2, Methylpropanediol, PEG-90 Glyceryl Isostearate, Peumus boldus Leaf Extract, Purified Water, Pyridoxine HCl, Sodium Laureth Sulfate, Sodium Metabisulfite, Sodium Salicylate, Spiraea ulmaria Extract, Tea Tree Oil, Vitamin F, Xanthan Gum, Zinc Gluconate

INSTRUCTIONS FOR USE

DIRECTIONS FOR USE: Shake well before use. Wet the hair coat with water and apply a thin line of shampoo from the base of the neck to the base of the tail. Massage shampoo over pet's body to ensure good contact with the skin. Allow to remain on hair coat for 5 to 10 minutes, then rinse thoroughly with clean water and repeat. May be used initially 2 to 3 times a week for 4 weeks, then reduce to once a week, or as directed by your veterinarian.

WARNINGS AND PRECAUTIONS

CAUTION: For animal use only. For external use only. Avoid contact with eyes or mucous membranes. Not for otic use. If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

WARNING: EYE IRRITANT. Avoid contact with eyes. In case of contact, flush eyes with water and seek medical attention if irritation persists. Wash hands after using.

Keep out of reach of children.

STORAGE AND HANDLING

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

QUESTIONS?
Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161
1-800-338-3659 us.virbac.com

302242-01

8 14514 02417 5

PRINCIPAL DISPLAY PANEL

Virbac, a pioneer in Veterinary Dermatology, offers a broad range of skin care products tailored to the individual needs of the pet, helping to improve quality of life.

USES: KERATOLUX® Shampoo with S-I-S SKIN INNOVATIVE SCIENCE® Technology is a unique cleanser that removes scales, crusts, and excess oil on the skin surface of dogs and cats. With regular bathing, KERATOLUX Shampoo helps manage normal sebum production, resulting in a pleasant smell and healthy appearance to the skin and coat.

• Improve hair coat and skin balance:

      ◊ removes excess sebum and scales       ◊ neutralizes unpleasant odors

• Support healthy skin with S-I-S SKIN INNOVATIVE SCIENCE Technology:

      ◊ Provides micro-organism anti-adhesive effects (Glycotechnology)
      ◊ Promotes natural skin microbial defenses (Defensin technology)

• Promote a healthy microbial balance in animals with keratoseborrheic conditions (Piroctone Olamine)

ACTIVE INGREDIENTS: Piroctone Olamine 0.5% w/w

INACTIVE INGREDIENTS: Alkylpolyglucoside, Butylene Glycol, Coco-Betaine, d-Galactose, d-Mannose, Disodium EDTA, Glycerin, l-Rhamnose, Laureth-2, Methylpropanediol, PEG-90 Glyceryl Isostearate, Peumus boldus Leaf Extract, Purified Water, Pyridoxine HCl, Sodium Laureth Sulfate, Sodium Metabisulfite, Sodium Salicylate, Spiraea ulmaria Extract, Tea Tree Oil, Vitamin F, Xanthan Gum, Zinc Gluconate

DIRECTIONS FOR USE: Shake well before use. Wet the hair coat with water and apply a thin line of shampoo from the base of the neck to the base of the tail. Massage shampoo over pet's body to ensure good contact with the skin. Allow to remain on hair coat for 5 to 10 minutes, then rinse thoroughly with clean water and repeat. May be used initially 2 to 3 times a week for 4 weeks, then reduce to once a week, or as directed by your veterinarian.

CAUTION: For animal use only. For external use only. Avoid contact with eyes or mucous membranes. Not for otic use. If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

WARNING: EYE IRRITANT. Avoid contact with eyes. In case of contact, flush eyes with water and seek medical attention if irritation persists. Wash hands after using.
Keep out of reach of children.

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

QUESTIONS?
Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161
1-800-338-3659 us.virbac.com

302239-01

8 14514 02209 6

NDC: 51311-072-08

Virbac

KERATOLUX®
(PIROCTONE OLAMINE)

MEDICATED SHAMPOO
FOR DOGS AND CATS

FOR MANAGEMENT
OF KERATOSEBORRHEIC
SKIN CONDITIONS

REMOVES SCALES, CRUSTS,

AND EXCESSIVE OIL ON THE

SKIN SURFACE

HELPS MAINTAIN SKIN

BARRIER INTEGRITY &

MICROBIAL BALANCE

S>I>S®
>SKIN
>INNOVATIVE
>SCIENCE

PURIFIES 

& CLEANSES

8 FL. OZ. (237 mL)

INGREDIENTS AND APPEARANCE

KERATOLUX 
piroctone olamine shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51311-072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PIROCTONE OLAMINE (UNII: A4V5C6R9FB) (PIROCTONE - UNII:R49EFA73Q7)	PIROCTONE OLAMINE	0.5 mg  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
COCO-BETAINE (UNII: 03DH2IZ3FY)
MANNOSE, D- (UNII: PHA4727WTP)
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURETH-2 (UNII: D4D38LT1L5)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
TEA TREE OIL (UNII: VIF565UC2G)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51311-072-08	1 in 1 CARTON
1		237 mg in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2018

Labeler - Virbac AH, Inc. (131568396)

Establishment
Name	Address	ID/FEI	Business Operations
Virbac Corporation		829166276	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Kumar Organic Products Limited		918155912	api manufacture