KINKAN COOL (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) LINIMENT [KINKANDO CO., LTD.]

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KINKAN COOL (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) LINIMENT [KINKANDO CO., LTD.]
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NDC 51027-0330-2
Set ID 82011efe-825c-4102-b6f1-59eff4c8040a
Category HUMAN OTC DRUG LABEL
Packager KINKANDO CO., LTD .
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Diphenhydramine Hydrochloride 2%

    Menthol 1%

  • Purpose

    Antihistamine

    External Analgesic

  • Uses

    Temporary relief of itching associate with insect bite

  • Warnings

    For external use only

    Flammable keep away from fire or flame

    Do not use on

    • wounds
    • damaged skin

    When using this product

    • avoid contact with the eyes and mouth

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms 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 and children 6 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 6 years of age: Do not use, consult a doctor.

  • Other Information

    • Store at room temperature under 86°F (30°C)
    • Flammable. keep away from fire or flame
  • Inactive ingredients

    Glycerin
    Geraniol-denatured Alcohol

  • Questions and comments

    Call 1-310-661-7260 Mon.-Fri. (2p.m. - 3p.m. PST)

  • Principal Display Panel - 50 mL Bottle Label

    NDC 51027-0330-2

    KINKAN
    COOL
    Liniment

    EXTERNAL
    ANTIPRURITIC
    LINIMENT

    MANUFACTURED BY
    KINKANDO CO., LTD.
    350-2 KODAMACHOKYOEI,
    HONJO-SHI, SAITAMA 367-0206,
    JAPAN

    DISTRIBUTED BY
    PMAI
    1700 W. WALNUT PARKWAY,
    COMPTON, CA 90220

    1.7 FL OZ (50mL)

    Principal Display Panel - 50 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    KINKAN COOL 
    diphenhydramine hydrochloride, menthol liniment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51027-0330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M) diphenhydramine hydrochloride1.00 g  in 50 mL
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol0.50 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    glycerin (UNII: PDC6A3C0OX)  
    alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51027-0330-296 in 1 CARTON04/26/2000
    11 in 1 BOX
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/26/2000
    Labeler - KINKANDO CO., LTD . (694329470)
    Establishment
    NameAddressID/FEIBusiness Operations
    KINKANDO CO., LTD .715451980MANUFACTURE(51027-0330)
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