Label: EARTHMED FS PAIN RELIEVING BALM- menthol salve

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 5, 2025

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  • Active Ingredients

    Menthol...........11.3%

    Purpose

    Menthol 11.3%.........................Topical Analgesic

    Purpose

    Menthol 11.3%.........................Topical Analgesic

  • Uses

    Temporary relief of aches and pains associated with arthritis, backache, joint pain, muscle strains, and sprains

  • Warnings

    FOR EXTERNAL USE ONLY, provides penetrating pain relief

  • When using this product

    Do not apply to wounds or irritated skin, and avoid contact with eyes

  • Stop use and ask a doctor if

    The condition worsens, symptoms last more than 7 days, the condition clears but occurs again within a few days, Rash or irritation occurs

    Stop use and ask a doctor if

    Condition worsens, Symptoms last more than 7 days, Condition clears up but occurs again within a few days, Rash or irritations occurs

  • If pregnant or breastfeeding

    Consult a health professional before use

    In case of an overdose

    seek medical help or contact a poison control center right away

  • Directions

    Adults and children 12 years and over; apply to the affected area one to four times daily

    Children 12 years and younger; ask a doctor

    Keep out of reach of children

    keep out of reach of children

    Keep out of reach of children

    keep out of reach of children

  • Other information

    Store at 68-77 degrees F, Avoid direct sunlight

  • Inactive ingredients

    Arnica Montana oil, Arrowroot powder, Beeswax, Full Spectrum Hemp Extract, Coconut oil, Rice bran oil, Rosemary oil, and Shea butter.

  • PRINCIPAL DISPLAY PANEL

    FS pain relieving balm label

  • INGREDIENTS AND APPEARANCE
    EARTHMED FS PAIN RELIEVING BALM 
    menthol salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82876-996
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.9 g  in 71.9 g
    Inactive Ingredients
    Ingredient NameStrength
    .DELTA.9-TETRAHYDROCANNABINOLIC ACID (UNII: EJ6CZV0K5Y) 0.036 g  in 71.9 g
    PEG-8 BEESWAX (UNII: 3C1QUF1TIR) 19.02 g  in 71.9 g
    JOJOBA OIL (UNII: 724GKU717M) 5.1 g  in 71.9 g
    COCONUT OIL (UNII: Q9L0O73W7L) 8.21 g  in 71.9 g
    ROSEMARY OIL (UNII: 8LGU7VM393) 0.59 g  in 71.9 g
    RICE BRAN OIL (UNII: LZO6K1506A) 11.51 g  in 71.9 g
    SHEA BUTTER (UNII: K49155WL9Y) 12.204 g  in 71.9 g
    CANNABIDIOL (UNII: 19GBJ60SN5) 2.25 g  in 71.9 g
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR) 4.22 g  in 71.9 g
    MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A) 0.86 g  in 71.9 g
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82876-996-4971.9 g in 1 TUBE; Type 0: Not a Combination Product08/05/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/05/2025
    Labeler - Earthmed LLC (118697474)
    Registrant - Earthmed LLC (118697474)
    Establishment
    NameAddressID/FEIBusiness Operations
    Earthmed LLC118697474manufacture(82876-996)
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