KERATOLUX (PIROCTONE OLAMINE) SHAMPOO [VIRBAC AH, INC.]

KERATOLUX (PIROCTONE OLAMINE) SHAMPOO [VIRBAC AH, INC.]
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NDC 51311-072-08
Set ID 3de5a071-e0eb-47ef-b2a7-236ef8dfd546
Category OTC ANIMAL DRUG LABEL
Packager Virbac AH, Inc.
Generic Name
Product Class
Product Number
Application Number
  • 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)

    image description2

  • INGREDIENTS AND APPEARANCE
    KERATOLUX 
    piroctone olamine shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51311-072
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB) (PIROCTONE - UNII:R49EFA73Q7) PIROCTONE OLAMINE0.5 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51311-072-081 in 1 CARTON
    1237 mg in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2018
    Labeler - Virbac AH, Inc. (131568396)
    Establishment
    NameAddressID/FEIBusiness Operations
    Virbac Corporation829166276manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Kumar Organic Products Limited918155912api manufacture

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