Label: DYNAREX MUSCLE RUB CREAM- menthol and methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL

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

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  • Active Ingredient

    Active Ingredient                                  Purpose

    Menthol 10%                                        Topical analgesic

    Methyl salicylate  15%  w/w                         Topical analgesic

  • 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.

  • Indications and Usage

    Uses

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

  • 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.
  • 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
  • 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.

  • 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.
  • Other Information

    Store at 20° - 25°C (68°-77°F)

  • 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.

  • Principal Display panel

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    Dynarex Cream

  • INGREDIENTS AND APPEARANCE
    DYNAREX MUSCLE RUB CREAM 
    menthol and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-416
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-416-0185 g in 1 TUBE; Type 0: Not a Combination Product05/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/16/2016
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)