Label: METHYL SALICYLATE 25% CREAM- methyl salicylate 25% cream

  • NDC Code(s): 81877-721-01
  • Packager: Forreal Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 2, 2024

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  • SPL UNCLASSIFIED SECTION

    Methyl Salicylate 25% Cream
    Forreal Pharmaceuticals, LLC

    ----------

    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 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 vera leaf, Glycerine, Arnica Montana Flower, Indian Frankincense, Cetostearyl Alcohol, Ethylhexylglycerin, Glucosamine Sulfate, Glyceryl Monostearate, C13-14 Isoparaffin, Isosteryl Palmitate, Trolamine, Stearic Acid, Propylene Glycol, Laureth-7, Peg-100 Stearate, Water, Phenoxyethanol

    Methyl Salicylate 25% Cream

    NDC: 81877-721-01

    120 grams

    Manufactured for:
    Forreal Pharmaceuticals, LLC
    Royal Oak, MI 48067

  • PRINCIPAL DISPLAY PANEL

    NDC: 81877-721-01
    Methyl Salicylate 25% Cream
    120 grams

    Manufactured For:

    Forreal Pharmaceuticals, LLC
    Royal Oak, MI 48067
    Questions or Comments Please call
    877-367-3250

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    METHYL SALICYLATE 25% CREAM 
    methyl salicylate 25% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81877-721
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81877-721-01120 g in 1 BOTTLE; Type 0: Not a Combination Product04/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drugpart34804/15/2024
    Labeler - Forreal Pharmaceuticals LLC (118029197)
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