Label: METHYL SALICYLATE 40 PERCENT- methyl salicylate cream

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

Drug Label Information

Updated October 31, 2023

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  • SPL UNCLASSIFIED SECTION

    Methyl Salicylate 40% Cream
    Alexso, Inc

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    Methyl Salicylate 40% Cream 

    ​Drug Facts

  • Active ingredient

    Methyl Salicylate 40%

  • Purpose

    Topical analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, 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 older: apply externally to the affected area up to 3 to 4 times a day

    Children under 2 years of age: consult 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 (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine

    Methyl Salicylate 40% Cream

    NDC: 50488-6040-6

    60 gram

    Manufactured for:
    Alexso, Inc
    2317 Cotner Ave
    Los Angeles, CA 90064

  • PRINCIPAL DISPLAY PANEL

    NDC 50488-6040-6
    Methyl Salicylate 40% Cream
    Net Wt. 2 oz. 60 g

    Rev 10/23

    PRINCIPAL DISPLAY PANEL NDC 50488-6040-6 Methyl Salicylate 40% Cream Net Wt. 2 oz. 60 g Rev 10/23

  • INGREDIENTS AND APPEARANCE
    METHYL SALICYLATE 40 PERCENT 
    methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-6040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50488-6040-660 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/01/2023
    Labeler - Alexso, Inc (963338061)
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