Label: KINKAN COOL- diphenhydramine hydrochloride, menthol liniment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 30, 2022

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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 g  in 50 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 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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