Label: JUST CBD ROLL-ON COOLING- menthol gel

  • NDC Code(s): 73647-004-03, 73647-400-03
  • Packager: Just Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 19, 2024

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  • ACTIVE INGREDIENT

    Menthol ………………………………...…………………………….…. 4%

  • PURPOSE

    Topical Analgesic

  • USES:

    Aid for temporary local relief of minor pain in muscles and joints.

  • WARNINGS

    • For external use only.

    • Ask a doctor before use if you have redness over affected area.

  • PREGNANCY OR BREAST FEEDING

    IF PREGNANT OR BREAST – FEEDING:

    Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS:

    Adults and Children over 12 years:

    Apply a small amount on the area to be.
    Massage in circular motion until absorbed, let set for a few seconds.
    Repeat as necessary, but no more than 3 to 4 times daily.

    Children under 12 years of age: Do not use, consult a doctor.

  • OTHER SAFETY INFORMATION

    Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
    Cannabidiol (CBD*) use, while taking any medication, or have any medical condition may be harmful. Consult
    a healthcare professional before use.

  • INACTIVE INGREDIENT

    Water (Aqua), Alcohol Denat, Ceteareth-25, Glycerin, Caprylic/Capric Triglyceride, Cannabidiol, Calendula Officinalis Extract, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Sodium Hydroxide, Carbomer, Methyl Salicylate, FD&C Blue No. 1 (CI 42090).

  • JUST CBD ROLL-ON COOLING GEL +1500

    cooling gel 1500

  • JUST CBD ROLL-ON COOLING GEL +350

    cooling 350

  • INGREDIENTS AND APPEARANCE
    JUST CBD ROLL-ON COOLING 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73647-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBIC ACID (UNII: X045WJ989B)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALCOHOL (UNII: 3K9958V90M)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73647-400-0389 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/14/2023
    JUST CBD ROLL-ON COOLING 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73647-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBIC ACID (UNII: X045WJ989B)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALCOHOL (UNII: 3K9958V90M)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73647-004-0389 mL in 1 BOTTLE; Type 0: Not a Combination Product03/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/14/2023
    Labeler - Just Brands LLC (113296558)
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