Label: DYNAREX MUSCLE RUB CREAM- menthol and methyl salicylate 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 June 15, 2017

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Active Ingredient                                  Purpose

    Menthol 10%                                        Topical analgesic

    Methyl salicylate  15%  w/w                         Topical analgesic

    Close
  • Purpose

    Temporary relief of minor aches and pains of muscle joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains

    Do not use other than directed.

    Close
  • Indications and Usage

    Uses

    Temporary relief of minor aches and pains of sore muscles and joints.

    Close
  • Warnings

    For external use only.

    • Avoid contact with the eyes or mucous membranes.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.
    • Do not use with heating pad or device.
    Close
  • Stop Use

    Stop Use And Ask A Doctor If:

    • Condition worsens, or if symptoms persist for more than 7 days,
    • symptoms clear up and occur again in a few days
    • redness is present or excessive skin irritation develops
    Close
  • Keep Out Of Reach Of Children

    KEEP OUT OF REACH OF CHILDREN

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

    Close
  • Dosage & Administration

    Directions

    • Use only as directed
    • Adults and children 12 years of age and older: apply to the affected areas not more than 3 or 4 times daily.
    • Children under 12 years of age: Consult a physician.
    Close
  • Other Information

    Store at 20° - 25°C (68°-77°F)

    Close
  • Inactive Ingredients

    Allantoin, carbomer, cetyl alcohol, dimethicone, disodium EDTA, glycerin, glyceral monostearate, isopropyl myristate, methyparaben, phenoxyethanol, potassium cetyl phoshate, propylparaben, purified water, sodium hydroxide, stearic acid, titanium dioxide, polysorbate 20, Vitamin E, xanthan gum.

    Close
  • Principal Display panel

    1135 GV.jpg

    Dynarex Cream

    Close
  • INGREDIENTS AND APPEARANCE
    DYNAREX MUSCLE RUB CREAM 
    menthol and methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-416
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALLANTOIN (UNII: 344S277G0Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67777-416-01 85 g in 1 TUBE; Type 0: Not a Combination Product 05/16/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 05/16/2016
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Close