Label: DR GOLDSONS PAIN- menthol 8%, methyl salicylate 30% cream

  • NDC Code(s): 72839-145-04
  • Packager: Derma Care Research Labs, LLC
  • 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 May 8, 2023

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  • ACTIVE INGREDIENT

    Menthol 8%, Methyl Salicylate 30%

  • PURPOSE


    External Analgesic

  • INDICATIONS & USAGE

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

  • WARNINGS

    For external use only. Do not use on wounds or damaged skin or with a heating pad. When using this product avoid contact with eyes or mucous membranes, do not bandage tightly. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days, excessive skin irritation occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Use only as directed. Adults and children over 12 years: apply to affected area not more than 3 to 4 times daily. Children 12 years oryounger: ask a doctor. Close cap tightly after use.

  • INACTIVE INGREDIENT

    Water, lanolin, glyceryl stearate SE, stearic acid, polysorbate 80, curcuma longa (turmeric) root extract, glycerin, carbomer, triethanolamine, potassium hydroxide, disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    DR GOLDSONS PAIN 
    menthol 8%, methyl salicylate 30% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-145
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TURMERIC (UNII: 856YO1Z64F)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-145-04113.4 g in 1 JAR; Type 0: Not a Combination Product09/21/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/21/2021
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(72839-145)
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