Label: MEDROX-RX- methyl salicylate, menthol, capsaicin ointment

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 27, 2011

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  • ACTIVE INGREDIENT

    methyl salicylate 20.00 % topical analgesic

    menthol 7.00 % topical analgesic

    capsaicin 0.050 % external analgesic

  • INACTIVE INGREDIENT

    acrylates copolymer, aloe barbadensis leaf (aloe vera gel) juice, aqua (deionized water), cetyl alcohol, ethylhexylglycerin, glycerin, isopropyl myristate, peg-150 disterate, phenoxyethanol, polysorbate-20, sodium lauryl sulfate, triethanolamine

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children. if swallowed, consult physician.

  • DOSAGE & ADMINISTRATION

    apply directly to affected area. do not use more than four times per day.

  • PURPOSE

    for temporary relief of minor aches and pains of the muscles and joints associated with simple arthritis, sprains, bruises and simple backache.

  • INDICATIONS & USAGE

    for temporary relief of minor aches and pains of the muscles and joints associated with simple arthritis, sprains, bruises and simple backache.
  • WARNINGS

    for external use only

    avoid contact with eyes

    do not bandage or wrap tightly

    do not apply to wounds or damages skin

    if symptoms persist for more than seven days, discontinue use and consult physician

    keep out of reach of children. if swallowed consult physician.

  • PRINCIPAL DISPLAY PANEL

    box image

                        Rx Only

    Medrox-Rx

    (medroxcin)     Pain relief ointment

    effecive, soothing, long lasting, paraben-free

  • INGREDIENTS AND APPEARANCE
    MEDROX-RX 
    methyl salicylate, menthol, capsaicin ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:45861-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    methyl salicylate (UNII: LAV5U5022Y) (methyl salicylate - UNII:LAV5U5022Y) methyl salicylate24 g  in 120 g
    menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol8.4 g  in 120 g
    capsaicin (UNII: S07O44R1ZM) (capsaicin - UNII:S07O44R1ZM) capsaicin0.6 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45861-005-01120 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34810/27/2011
    Labeler - Pharmaceutica North America, Inc. (962739699)
    Registrant - Pharmaceutica North America, Inc. (962739699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source969241041manufacture
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