Label: PURE PERSONAL ALL NATURAL PAIN RELIEF CREAM- menthol cream

  • NDC Code(s): 83072-374-00
  • Packager: PURE PERSONAL CARE, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active Ingredients

    Menthol 7.5 %

    Purpose

    Topical Analgesic

  • Uses:

    • For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains. 

  • Warnings:

    For external use only.

    Do not use

    • on damaged or broken skin.

    When using this product 

    • Avoid contact with the eyes • Do not bandage tightly.

    Stop use and ask a doctor if

    • rash or irritation develops and lasts • condition worsens, or if symptoms persist for more than 7 days or 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.

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions:

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: consult a doctor.

  • Other information:

    • Protect the product in this container from excessive heat and direct sun.

  • Inactive ingredients:

    Aqua (Deionized Water), Beeswax, Boswellia Carterii (Frankincense) Oil, Camphor, Cannabis Sativa (Hemp) Seed Oil, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, Eucalyptus Globulus Oil, Eugenia Caryophyllus (Clove) Bud Oil, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Isopropyl Alcohol, Mangifera Indica (Mango) Butter, Mentha Piperita (Peppermint) Oil, Methyl Salicylate, Tocopherol (Vitamin E), Xanthan Gum.

  • Questions or comments?

    419-461-9916

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    PURE PERSONAL ALL NATURAL PAIN RELIEF CREAM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83072-374
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CLOVE OIL (UNII: 578389D6D0)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MANGO (UNII: I629I3NR86)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83072-374-0059 mL in 1 JAR; Type 0: Not a Combination Product10/24/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/24/2022
    Labeler - PURE PERSONAL CARE, LLC (085296835)
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