Label: OSTEO BI-FLEX JOINT HEALTH PAIN RELIEVING- menthol, methyl salicylate cream

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

Drug Label Information

Updated November 10, 2023

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  • Drug Facts

  • Active ingredients

    Menthol 5%

    Methyl Salicylate 10%

    Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with: - arthritis - simple backache - strains - bruises - sprains

  • Warnings

    For external use only.

    When using this product

    • Use only as directed
    • Avoid contact with eyes and mucous membranes
    • Do not apply to wounds or damaged, broken or irritated skin
    • Do not bandage tightly or apply local heat (such as heating patches) to the area of use

    Discontinue use and consult a doctor if

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • Irritation develops/excessive irritation occurs

    If pregnant or breastfeeding

    ask a health care professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. For best results apply daily or as directed by a physician
    • After applying, wash hands with soap and water. Children under 12 years of age: consult a doctor.
  • Inactive ingredients

    aloe barbadensis juice, boswellia serrata extract, carbomer, chondroitin sulfate, ethylhexylglycerin, glucosamine sulfate, glyceryl stearate SE, lanolin, magnesium sulfate, methylsulfonylmethane, phenoxyethanol, polysorbate 80, propylene glycol, stearic acid, triethanolamine, water.

  • Questions?

    call 1-888-VITAHELP (848-2435)

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    OSTEO BI-FLEX JOINT HEALTH PAIN RELIEVING 
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59118-837
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59118-837-011 in 1 BOX08/01/2017
    171 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/01/2017
    Labeler - Rexall Sundown, LLC (080774588)
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