Label: DYNARUB- pain relieving cream 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 January 15, 2019

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

  • Active Ingredient

    Menthol 10%

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  • Purpose

    Topical Analgesic

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  • Active Ingredient

    Methyl Salicylate 15%

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  • Purpose

    Topical Analgesic

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  • Uses

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

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  • Warnings

    For external use only

    Do not use on

    wounds or damaged skin

    When using this product

    • avoid contact with eyes
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
    • Children under 2 years of age: Consult a doctor
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  • Other Information

    store at 20°-25°C (68°-77°F).

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  • Inactive Ingredients


    Allantoin, Carbomer (Ultrez 10), Cetyl Alcohol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methyl Paraben, Phenoxyethanol, Potassium Cetyl Phosphate, Propyl Paraben, Purified Water, Sodium Hydroxide, Stearic Acid, Titanium Dioxide, Tween 20, Vitamin E, Xanthan Gum

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  • Label
  • INGREDIENTS AND APPEARANCE
    DYNARUB 
    pain relieving cream cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-113
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    WATER (UNII: 059QF0KO0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67777-113-50 72 in 1 CASE 09/12/2016
    1 85 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/12/2016
    Labeler - Dynarex Corporation (008124539)
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