KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION [AVLON INDUSTRIES, INC.]

KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION [AVLON INDUSTRIES, INC.]
PDF | XML

NDC 63766-004-01, 63766-004-02
Set ID 90963011-c636-452c-a3f5-6368e139fe3e
Category HUMAN OTC DRUG LABEL
Packager Avlon Industries, Inc.
Generic Name
Product Class
Product Number
Application Number PART358H
  • Drug Facts

    Active Ingredient                                                                              

    Pyrithione Zinc 0.2%

    Purpose

    Anti-Dandruff

  • INDICATIONS & USAGE

    Use for the relief of flaking, itching and irritation Associated with dandruff.

    -----------------------------------------------------------------------------------------------------

  • Warnings

    ■ For external use only

    -----------------------------------------------------------------------------------------------------

  • Ask a doctor if

    ■ Condition worsens or does not improve with regular use.

    -----------------------------------------------------------------------------------------------------

  • WHEN USING

    When using this product

    ■ Avoid getting into eyes. In event of contact, rinse eyes thoroughly with water.

    -----------------------------------------------------------------------------------------------------

  • STOP USE

    Stop use and ask a doctor if

    ■ Condition worsens or does not improve with regular use.

    -----------------------------------------------------------------------------------------------------

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact

    a Poison Control Center right away.

    -----------------------------------------------------------------------------------------------------

  • Directions

    • Apply daily or several times a day as needed.
    • Massage gently into scalp.
    • Do not rinse out.

    -----------------------------------------------------------------------------------------------------

  • Inactive Ingredients

    Water/Aqua/Eau, Mineral Oil, Petrolatum, Beeswax, Cetyl Alcohol, Lanolin, Sodium Borate, Polysorbate 60,

    Polysorbate 80, Carthamus Tinctorius (Safflower) Seed Oil, Eugenia Caryophyllus (Clove) Flower Extract,

    Glyceryl Stearate, Menthol, Sulfur, Perfume, BHT, Methylisothiazolinone, A-Isomenthyl Ionone, Benzyl Alcohol,

    Benzyl Benzoate, Benzyl Cinnamate, Benzyl Salicylate, Butylphenyl Methylpropional, Cinnamal Alcohol, Citronellol,

    Geraniol, Hexyl Cinnamal, Hydroxycitronellal, Hydroxyisohexyl 3-cyclohexane Carboxaldehyde, d-Limonene, Linalool.

  • SPL UNCLASSIFIED SECTION

    ©2014 Manufactured by Avlon Industries, Inc.,

    1999 N. 15th Avenue, Melrose Park, IL 60160 USA

    77 Oxford Street, London, W1D 2ES, UK  www. Avlon.com

  • Package Label. Principal Display Panel

    KeraCare® Anti-Dandruff Spot Itch Lotion controls itching and dandruff in between weekly

    services. Best dandruff defense when used in conjunction with KeraCare Dry & Itchy Scalp

    Moisturizing Shampoo and Conditioner.

    llabelspotitchlotion_samplelabelspotitchlotion_2oz

  • INGREDIENTS AND APPEARANCE
    KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF 
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63766-004
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LANOLIN (UNII: 7EV65EAW6H)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CLOVE (UNII: K48IKT5321)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MENTHOL (UNII: L7T10EIP3A)  
    SULFUR (UNII: 70FD1KFU70)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63766-004-0160 mL in 1 TUBE; Type 0: Not a Combination Product06/18/2009
    2NDC:63766-004-027.5 mL in 1 POUCH; Type 0: Not a Combination Product06/18/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/18/2009
    Labeler - Avlon Industries, Inc. (121278626)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avlon Industries, Inc.121278626manufacture(63766-004)

Related Drugs