Label: METHYL SALICYLATE 25% CREAM- methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 14, 2025

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  • Active ingredient

    Methyl Salicylate 25%

  • Purpose

    External 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

    Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum.

    MANUFACTURED FOR:
    Marcella Health

    Cheyene, WY 82001
    Questions or Comments
    (307) 410-3813 or info@marcellahealth.com

  • PRINCIPAL DISPLAY PANEL

    Drug Facts:

    Methyl Salicylate Box

  • INGREDIENTS AND APPEARANCE
    METHYL SALICYLATE 25% CREAM 
    methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85096-001
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE250 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85096-001-42120 g in 1 TUBE; Type 0: Not a Combination Product04/15/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/15/2025
    Labeler - MARCELLA HEALTH (119381899)
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