KERACARE (MENTHOL 1%) GEL [AVLON INDUSTRIES, INC.]

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KERACARE (MENTHOL 1%) GEL [AVLON INDUSTRIES, INC.]
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NDC 63766-001-01, 63766-001-02
Set ID f72eec6d-1204-4e03-8aed-d5bcf8d3bbce
Category HUMAN OTC DRUG LABEL
Packager Avlon Industries, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • ACTIVE INGREDIENT

    Menthol 1.00%

  • PURPOSE

    Topical Analgesic

  • USE

    for the temporary relief of itching associated with minor skin irritations of the scalp.

  • WARNINGS

    for external use only

  • When using this product

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

  • Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults: Apply to scalp at least twice per week. Use daily for maximum results. Children: Consult a physician.

  • INACTIVE INGREDIENTS

    Petrolatum, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Paraffin, Polyethylene, Salicylic Acid, Tocopheryl Acetate, Fragrance/Parfum, Olea Europaea (Olive) Fruit Oil, BHT, Sulfur, Alpha-Isomethyl Ionone, Amyl Cinnamal, Benzyl Salicylate, Eugenol, Geraniol, Hydroxycitronellal, Isoeugenol, Limonene, Linalool, Red 17/CI 26100.

  • PRINCIPAL DISPLAY PANEL

    KeraCare Glossifier

    Product NDC 63766-001

    Label

  • INGREDIENTS AND APPEARANCE
    KERACARE 
    menthol 1% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63766-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SULFUR (UNII: 70FD1KFU70)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    EUGENOL (UNII: 3T8H1794QW)  
    GERANIOL (UNII: L837108USY)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    ISOEUGENOL (UNII: 5M0MWY797U)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    D&C RED NO. 17 (UNII: ND733RX3JN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63766-001-02200 g in 1 CANISTER; Type 0: Not a Combination Product04/06/2014
    2NDC:63766-001-01110 g in 1 CANISTER; Type 0: Not a Combination Product04/06/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/06/2014
    Labeler - Avlon Industries, Inc. (121278626)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avlon Industries, Inc.121278626manufacture(63766-001)
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