Label: EARTHMED FS MASSAGE OIL- allantoin oil

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

Drug Label Information

Updated August 5, 2025

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  • Active ingredients

    Allantoin......1%

    Purpose

    Skin protectant

  • Uses

    Helps prevent and temporarily protect and help relieve chafed, chapped, or cracked skin.

    Helps prevent and protect from the drying of wind and cold weather

  • Warnings

    For external use only.

  • Do not use

    on deep or puncture wounds, animal bites, serious burns

  • When using this product

    Do not get into eyes

    Stop use and ask doctor if

    condition worsens, symptoms last for more than 7 days, condition clears up but occurs again within a few days, rash or irritation occurs

    Stop use and ask doctor if

    Condition worsens, Symptoms last for more than 7 days, condition clears up but occurs again in a few days, rash or irritation occurs

  • If pregnant or breast feeding

    Consult a health professional before use.

    in case of overdose

    seek medical help or contact a poison control center right away

  • Directions

    shake well before use.

    adults and children 2 years and over; apply as needed.

    children under 2 years; consult a doctor

    keep out of reach of children

    Keep out of reach of children

  • Other information

    Store at 68-77 degrees F (20-25 degrees C), avoid direct sunlight

  • inactive ingredients

    Arnica montana, Cannabidiol, Jojoba oil, Lavender oil, Peppermint oil, Rice bran oil, Sweet almond oil.

  • PRINCIPAL DISPLAY PANEL

    Massage oil label

  • INGREDIENTS AND APPEARANCE
    EARTHMED FS MASSAGE OIL 
    allantoin oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82876-986
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1 g  in 108.48 g
    Inactive Ingredients
    Ingredient NameStrength
    RICE BRAN OIL (UNII: LZO6K1506A) 65.235 g  in 108.48 g
    LAVENDER OIL (UNII: ZBP1YXW0H8) 0.28 g  in 108.48 g
    PEPPERMINT OIL (UNII: AV092KU4JH) 0.15 g  in 108.48 g
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR) 2.85 g  in 108.48 g
    ALMOND OIL (UNII: 66YXD4DKO9) 27.2 g  in 108.48 g
    JOJOBA OIL (UNII: 724GKU717M) 10.58 g  in 108.48 g
    CANNABIDIOL (UNII: 19GBJ60SN5) 1.13 g  in 108.48 g
    .DELTA.9-TETRAHYDROCANNABINOLIC ACID (UNII: EJ6CZV0K5Y) 0.055 g  in 108.48 g
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82876-986-34108.48 g in 1 BOTTLE; Type 0: Not a Combination Product08/04/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/04/2025
    Labeler - Earthmed LLC (118697474)
    Registrant - Earthmed LLC (118697474)
    Establishment
    NameAddressID/FEIBusiness Operations
    Earthmed LLC118697474manufacture(82876-986)
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