Label: METHYL SALICYLATE 25% CREAM- methyl salicylate cream

  • NDC Code(s): 82461-415-05, 82461-415-10
  • Packager: Medcore LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 14, 2025

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  • ​

    Drug Facts

  • Active ingredient

    Methyl Salicylate 25%

  • Purpose

    Topical analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

  • Warnings

    ​For external use only.

    When using this product

    -
    Avoid contact with the eyes
    -
    Do not use in larger quantities, particularly over raw surfaces or blistered areas
    -
    Do not apply to wounds or damaged skin
    -
    Do not bandage

    Stop use and ask a doctor if

    -
    allergic reaction occurs
    -
    condition worsens or does not improve within 7 days
    -
    symptoms clear up and return within a few days
    -
    redness, irritation, swelling, pain or other symptoms begin or increase

    Keep out of the reach of children.

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

  • Directions

    adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day
    children under 2 yearsask a doctor
  • Other Information

    -
    May be applied under occlusive dressing.
    -
    Store at 20-25-C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.
  • Inactive Ingredients

    Glycerine, CETOSTEARYLALCOHOL, ETHYLHEXYLGLYCERIN, GLUCOSAMINE SULFATE, CHONDROITIN SULFATE, (BOVINE), GLYCERYL MONOSTEARATE, C13-14ISOPARAFFIN, ISOSTEARYL PALMITATE, TROLAMINE, STEARIC ACID, PROPYLENE GLYCOL, LAURETH-7, PEG-100 STEARATE, Water, PHENOXYETHANOL.

    Manufactured For:
    Medcore LLC
    3048 Valley Rd.
    Basking Ridge, NJ 07920
    Questions or Comments Please call
    908-280-2269

  • PRINCIPAL DISPLAY PANEL

    NDC: 82461-415-10

    Medcore LLC

    Methyl Salicylate 25% Cream

    120mL

    Manufactured For:
    Medcore LLC
    3048 Valley Rd.
    Basking Ridge, NJ 07920
    Questions or Comments Please call
    908-280-2269

    Label-1

  • PRINCIPAL DISPLAY PANEL

    NDC: 82461-415-05

    Medcore LLC

    Methyl Salicylate 25% Cream

    50mL

    Manufactured For:
    Medcore LLC
    3048 Valley Rd.
    Basking Ridge, NJ 07920
    Questions or Comments Please call
    908-280-2269

    Label-2

  • INGREDIENTS AND APPEARANCE
    METHYL SALICYLATE 25% CREAM 
    methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82461-415
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE250 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 60 mg  in 1 mL
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 10 mg  in 1 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 20 mg  in 1 mL
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) 10 mg  in 1 mL
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z) 5 mg  in 1 mL
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 10 mg  in 1 mL
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70) 10 mg  in 1 mL
    ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1) 30 mg  in 1 mL
    TROLAMINE (UNII: 9O3K93S3TK) 20 mg  in 1 mL
    STEARIC ACID (UNII: 4ELV7Z65AP) 30 mg  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 50 mg  in 1 mL
    LAURETH-7 (UNII: Z95S6G8201) 30 mg  in 1 mL
    PEG-100 MONOSTEARATE (UNII: YD01N1999R) 50 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 410 mg  in 1 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 5 mg  in 1 mL
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82461-415-10120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/14/2025
    2NDC:82461-415-0550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/14/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/14/2025
    Labeler - Medcore LLC (069802634)
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