Label: EVERFLEX TOPICAL ANALGESIC PAIN RELIEF WITH MSM- menthol 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 April 14, 2021

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  • ACTIVE INGREDIENT

    Active Ingredients                         Purpose

    Menthol 1.25%                              Topical analgesic

  • PURPOSE

    Use

    For temporary relief of minor aches and pains associated with with simple backache, arthritis, strains, bruises and sprains.

  • KEEP OUT OF REACH OF CHILDREN


    -Keep out of reach of children

  • INDICATIONS & USAGE


    -If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of product and consult a physician

    -Do not apply to wounds or damaged skin

    -Do not bandage tightly

  • WARNINGS

    Warnings

    -For external use only
    -Avoid contact with eyes

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 2 yrs of age and and older. Apply to affected area not more than 3 to 4 times per day.
    • Children under 2 yrs of age: Consult a physician
  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Glyceryl Stearate, Glycerin, Methylsulfonylmethane (MSM), Cetyl Myristoleate, Olea Europaea (Olive) Fruit Oil, Cetyl Myristate, Lecithin, Tocopheryl Acetate, Benzyl Alcohol, Phenoxyethanol, Carbomer, PEG-100 Stearate, Potassium Hydroxide, Cetyl Palmitoleate, Cetyl Oleate, Cetyl Palmitate, Cetyl Laurate, Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben

  • PRINCIPAL DISPLAY PANEL


    Everflex Topical Analgesic Pain Relief Cream with MSM

    2 fl oz. (58.7 mL)

    everflex 2B

  • INGREDIENTS AND APPEARANCE
    EVERFLEX TOPICAL ANALGESIC PAIN RELIEF WITH MSM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61582-533
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CETYL MYRISTATE (UNII: 7OPL833Q4D)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CETYL PALMITOLEATE (UNII: 962I97113K)  
    CETYL OLEATE (UNII: 78K2L26L8N)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61582-533-0158.7 mL in 1 JAR; Type 0: Not a Combination Product04/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/23/2021
    Labeler - Natures Sunshine Products, Inc. (809048960)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wasatch Product Development, LLC962452533manufacture(61582-533)
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