Label: METHYL SALICYLATE cream

  • 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 August 3, 2023

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  • SPL UNCLASSIFIED SECTION

    Methyl Salicylate 25% Cream
    Alexso, Inc

    ----------

    Methyl Salicylate 25% 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 older

    apply 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, 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, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine

    Methyl Salicylate 25% Cream

    NDC: 68788-7925-1

    120 grams

    Manufactured for:
    Alexso, Inc
    Los Angeles, CA 90064

  • PRINCIPAL DISPLAY PANEL

    NDC 68788-7925-1
    Methyl Salicylate 25% Cream
    120 grams

    Relabeled By: Preferred Pharmaceuticals Inc.

    Methyl Salicylate 25% Cream
  • INGREDIENTS AND APPEARANCE
    METHYL SALICYLATE 
    methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7925(NDC:50488-1015)
    Route of AdministrationTOPICAL
    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
    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)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-7925-1120 g in 1 BOTTLE; Type 0: Not a Combination Product08/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/13/2021
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7925)
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