Keratolux: Product Information

KERATOLUX- piroctone olamine shampoo
Virbac AH, 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.

MEDICATED SHAMPOO FOR DOGS AND CATS

FOR MANAGEMENT OF KERATOSEBORRHEIC CONDITIONS

REMOVES SCALES, CRUSTS, & EXCESSIVE OIL ON THE SKIN SURFACE

HELPS MAINTAIN SKIN BARRIER INTEGRITY & MICROBIAL BALANCE

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 Clamine)

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 apple 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 IRRITA NT. 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

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KERATOLUX
piroctone olamine shampoo
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:51311-072
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIROCTONE OLAMINE (PIROCTONE) PIROCTONE OLAMINE 0.5 mg in 1 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-072-08 237 mg in 1 BOTTLE None
2 NDC:51311-072-16 473 mg in 1 BOTTLE None
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)
Registrant — Virbac AH, Inc. (131568396)
Establishment
Name Address ID/FEI Operations
Virbac Corporation 829166276 manufacture, label, pack

Revised: 06/2022 Virbac AH, Inc.

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