Label: METHYL SALICYLATE 25 PERCENT- methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 23, 2024

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  • SPL UNCLASSIFIED SECTION

    Methyl Salicylate 25% Pump Bottle Cream 

    ​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 large 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 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 years ask 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

    Aqua (Deionized Water), Arnica Montana Flower Extract, Indian Frankincense, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Monostearate, Cetostearyl Alcohol, Aloe Vera Leaf, C13-14 Isoparaffin, Isostearyl Palmitate, Trolamine, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Stearic Acid.

    Methyl Salicylate 25% Pump Bottle Cream

    NDC: 50488-1016-5

    50 mL

    Manufactured for:
    Alexso, Inc
    Los Angeles, CA 90064

    Tel: 888.495.6078

  • PRINCIPAL DISPLAY PANEL

    NDC 50488-1016-5
    Methyl Salicylate 25% Pump Bottle Cream
    50 mL

    Rev 05/24

    NDC 50488-1016-5 Methyl Salicylate 25% Pump Bottle Cream 50 mL Rev 05/24

  • INGREDIENTS AND APPEARANCE
    METHYL SALICYLATE 25 PERCENT 
    methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-1016
    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
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50488-1016-550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/01/2024
    Labeler - Alexso, Inc (963338061)
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