Label: MENTHOL- owell naturals pain relief cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 17, 2023

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  • Active Ingredient

    Menthol 8%

  • Purpose

    Topical Analgesic

  • Uses:

    Arthritis Pain, Sore Joints and Muscles, Sore Throat, Sinus Trouble, Restless Leg Syndrome

  • Warnings

    • For External Use Only, As Directed!
    • Avoid contact with eyes or other sensitive areas.
    • If prone to allergic reaction from asprin or salicylate, consult your doctor before using.
    • If conditions persist pore than seven days, consult your doctor
    • If pregnant or breast-feeding, ask a health professional before use.
    • Do not bandange tightly or use a heating pad
    • May irritate sensitive skin

    • Keep ointment out of reach of children
  • Directions

    ​Adults and children over 12 years:

    • ​Apply freely to affected areas. Rub well
    • ​Colds: ​Apply on chest, back and neck.
    • ​Head Colds: Apply around nostrils, on forehead and behind ears.  Place small amount in vaporizer for aid.
    • ​Sore Throat:​ Apply  liberally on throat and neck for sore throats

    Children 12 years or younger.

    • Consult your physician.
  • INACTIVE INGREDIENTS

    Water, Carthamus Tinctorius (Hybrid Safflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe Barbadensis (Aleo Vera) Leaf Juice, Beeswax, Hydrogenated Castor oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus Globulus Leaf Oil, Chlorphenesin, Cinnamomum Camphora Bark Oil, Abies Sibirica Needle Oil, Methyl Salicylate, Sodium Chloride

  • PRINCIPAL DISPLAY PANEL

    7FL OZ Pain Relief Cream label

  • INGREDIENTS AND APPEARANCE
    MENTHOL 
    owell naturals pain relief cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62212-505
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    CINNAMOMUM CAMPHORA WHOLE (UNII: 0B27814T7X)  
    ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62212-505-01198.45 g in 1 JAR; Type 0: Not a Combination Product07/17/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/17/2023
    Labeler - Amish Origins LLC (079239259)
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