Label: GREEN COMPASS REDUCE ROLL-ON PAIN RELIEF- menthol liquid

  • Category: HUMAN OTC DRUG LABEL

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 January 1, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Menthol 5%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    For temporary relief of minor aches and pains of muscles and joints.

  • WARNINGS

    Warnings

    For external use only.

    Do not use

    • on wounds or damaged skin
    • with a heating pad

    When using this product

    • avoid contact with the eyes
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days
    • condition clears up and occurs again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water (Aqua), Full Spectrum Hemp Flower Extract, Hydroxyethylcellulose, Ethyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Heptyl Glucoside, Organic Aloe Barbadensis Leaf Juice, Tocopherol, Arnica Montana (Arnica) Flower Extract, Cinnamomom Camphora (Camphor) Bark Oil, Lavandula Angustifolia (Lavender) Flower Oil, Xanthan Gum, Glyceryl Caprylate, Caprylhydroxamic Acid.

  • SPL UNCLASSIFIED SECTION

    Distributed By:

    Green Compass, Inc.

    1121 Military Cutoff Rd., Ste C339

    Wilmington, NC 28405 USA

  • PRINCIPAL DISPLAY PANEL

    REDUCE

    ROLL-ON PAIN RELIEF

    WITH MENTHOL AND 300 mg FULL SPECTRUM HEMP FLOWER EXTRACT

    GREEN COMPASS

    2 FL OZ (60 mL)

    GRC 176 Reduce Roll-on Final

  • INGREDIENTS AND APPEARANCE
    GREEN COMPASS REDUCE ROLL-ON PAIN RELIEF 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73132-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    HEPTYL GLUCOSIDE (UNII: BU2OC48XBR)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CANNABIS SATIVA FLOWERING TOP (UNII: 8X454SZ22D)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73132-003-601 in 1 CARTON12/03/2020
    160 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/03/2020
    Labeler - Green Compass, Inc. (105963322)
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