Label: COOLING ESSENTIAL OIL- mentholum, camphor oil

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated November 24, 2021

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  • ACTIVE INGREDIENT

    Mentholum 25%, Camphor 20%, Borneol 5%, Menthyl Lactate 5%, Mentha Haplocalyx Oil 2%

  • PURPOSE

    Refresh brain / Relieve dizziness and fatigue / Relieve stuff noses / Mosquito-repellent and relieve itching / Fresh air

  • WARNINGS

    For external use only.

    When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • Stop use and ask a doctor

    If irritation or rash appears and lasts, stop use the product.In case of accidental ingestion, contact a doctor

  • KEEP OUT OF REACH OF CHILDREN

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

  • INSTRUCTIONS FOR USE

    Upper layer: Unscrew the upper cap and inhale close to your nose.

    Lower layer: Unscrew the lower cap and apply to the skin surface.

  • INACTIVE INGREDIENT

    Isopropyl Myristate, Alcohol, Cymbopogon Citratus Extract, Blumea Balsamifera Oil.

  • DOSAGE & ADMINISTRATION

    Max 4 times on day

  • INDICATIONS & USAGE

    Unscrew the upper cap and inhale close to your nose.

    Unscrew the lower cap and apply to the skin surface.

  • PRINCIPAL DISPLAY PANEL

    oil

  • INGREDIENTS AND APPEARANCE
    COOLING ESSENTIAL OIL 
    mentholum, camphor oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82421-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHYL LACTATE, (-)-5 mg  in 100 mL
    MENTHA CANADENSIS TOP (UNII: 610T51U707) (MENTHA CANADENSIS TOP - UNII:610T51U707) MENTHA CANADENSIS TOP2 mg  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 100 mL
    CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL20 mg  in 100 mL
    BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X) BORNEOL5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82421-001-012 mL in 1 BOTTLE; Type 0: Not a Combination Product11/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/25/2021
    Labeler - Shenzhen E-commerce Trading Co., Ltd (699362247)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen E-commerce Trading Co., Ltd699362247manufacture(82421-001) , label(82421-001)
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