Label: MEDI-DERM RX- methyl salicylate, menthol and capsaicin cream

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 6, 2019

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  • ACTIVE INGREDIENT

    Active ingredients                             

    Capsaicin 0.035%
    Menthol 5%
    Methyl Salicylate 20%

  • PURPOSE

    PURPOSE

    TOPICAL ANALGESIC

  • INDICATIONS & USAGE

    USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.

  • WARNINGS

    Warnings: For external use only.

    • Use only as directed.
    • Avoid contact with eyes and mucous membranes.
    • Do not use with heating devices or pads.
    • Do not cover or bandage tightly.
    • If swallowed, call poison control.
    • If contact does occur with eyes rinse with cold water and call a doctor.
  • DO NOT USE

    DO NOT USE: ON WOUNDS OR DAMAGED SKIN. CHILDREN UNDER 12 YEARS OLD, CONSULT A DOCTOR. IF YOU ARE ALLERGIC TO ANY INGREDIENTS IN THIS PRODUCT.

  • DOSAGE & ADMINISTRATION

    Directions: Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Carbomer, Cetearyl Alcohol, Cypress Oil, Glyceryl Stearate, Green 3 (CI# 42053), Hypromellose, Isopropyl Palmitate, Methylisothiazolinone, Phenoxyethanol, Polysorbate-60, Propylene Glycol, Sodium Hydroxide, Stearyl Alcohol, Water.

  • OTHER SAFETY INFORMATION

    OTHER INFORMATION: STORE BELOW 90°F/32°C

  • QUESTIONS

    QUESTIONS? 888 907-2833

  • ASK DOCTOR

    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 THIS PRODUCT AND CONSULT A DOCTOR.

  • PREGNANCY

    IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    Medi-Derm-Rx_151-14

  • INGREDIENTS AND APPEARANCE
    MEDI-DERM  RX
    methyl salicylate, menthol and capsaicin cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76074-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 mL
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.035 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYPERUS ESCULENTUS LEAF (UNII: T1004HC0OF)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76074-151-14120 mL in 1 TUBE; Type 0: Not a Combination Product08/18/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/18/2012
    Labeler - Two Hip Consulting, LLC (965352896)
    Registrant - Two Hip Consulting, LLC (965352896)
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