Label: COOLING ESSENTIAL OIL- mentholum, camphor oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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