Label: PAIN BE GONE- menthol cream

  • NDC Code(s): 82721-001-01, 82721-001-02
  • Packager: Back to Earth Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 13, 2023

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  • Active Ingredients

    Menthol 9.6%

  • PURPOSE

    Pain Relieving Gel

  • WARNINGS

    ■ For external use only.
    ■ Avoid Contact with the eyes. If conditions worsen, or if symptoms
    persist for more that 7 days or clear up and occur again within a few
    days, discontinue use of this product and consult a physician/doctor.
    ■ Do not apply to wounds or damaged skin.

    ■ Do not bandage tightly.

    ■ Keep out of reach of children. In case of overdose, get medical help
    or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    ■ 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 Physician/Doctor

  • INDICATIONS & USAGE

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

  • INACTIVE INGREDIENT

    Purified Water, Caprylhydroxamic Acid, Glyceryl caprylate, Glycerin,
    Mentha Arvensis (Peppermint) Oil, Arnica (Arnica Montana) Macerated Oil
    Rosmarinus Officinalis (Rosemary) Oil, Citrus Limonum (Lemon) Organic Oil,
    Eucalyptus Globulus (Eucalyptus) Oil, Gaultheria Procumbens
    (Wintergreen) Oil, Cinnamomum Camphora (White) Oil,
    Pinus Sylvestris (Scotch Pine) Oil, Sodium Carbomer, Polysorbate 80.

  • KEEP OUT OF REACH OF CHILDREN

    ■ Keep out of reach of children. In case of overdose, get medical help
    or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    PAIN BE GONE 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82721-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL9.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X)  
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82721-001-0150 mL in 1 TUBE; Type 0: Not a Combination Product07/27/2023
    2NDC:82721-001-02120 mL in 1 TUBE; Type 0: Not a Combination Product07/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01407/27/2023
    Labeler - Back to Earth Inc. (203365416)
    Registrant - Back to Earth Inc. (203365416)
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