Label: METHYL SALICYLATE 40% TOPICAL OIL- methyl salicylate liquid

  • NDC Code(s): 81877-620-04
  • Packager: FORREAL PHARMACEUTICALS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 10, 2023

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  • ACTIVE INGREDIENT

    Active ingredient: Methyl Salicylate 40%

  • PURPOSE

    Purpose: Topical Analgesic

  • INDICATIONS & USAGE

    Uses: Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, sprains, bruises.

  • WARNINGS

    Warning: For external use only. DO NOT USE IF ALLERGIC TO PEANUTS

  • ASK DOCTOR

    Ask a doctor before use if you have a propensity for allergic reactions to aspirin or salicylate or peanuts.

  • WHEN USING

    When using the product: Do not use in or near the eyes or mucous membranes; if the product gets into the eyes, rinse thoroughly with cold water. Do not bandage tightly or use with hot pads.

  • STOP USE

    Stop use and ask doctor if symptoms last more than 7 days or clear up and occur again within a few days. Or condition worsens or rash or irritation develops.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. if swallowed, get medical help or contract a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 years of age and older; apply generously to affected area. Massage vigorously into painful areas until absorbed completely. Repeat as needed, but do not use more than three times daily. Children under 12 years of age, ask a doctor.
    Other information: Store at room tempreature. Protect from light and heat. Close cap tightly after use.

  • INACTIVE INGREDIENT

    Inactive ingredient: Peanut Oil.

    Packaged For:
    Forreal Pharmaceuticals LLC
    Royal Oak, MI 48067
    Question or Comments please call 877-367-3250

  • PRINCIPAL DISPLAY PANEL

    NDC: 81877-620-04            4 Fluid oz.

    Methyl
    Salicylate 40%

    Topical Rubbing Oil

    For Temporary Relief of Minor Pains.

    DO NOT USE IF ALLERGIC TO PEANUTS

    Forreal Pharmaceuticals LLC
    YOUR SOLUTION TO BETTER HEALTHCARE

    Methyl Salicylate 40%

  • INGREDIENTS AND APPEARANCE
    METHYL SALICYLATE 40% TOPICAL OIL 
    methyl salicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81877-620
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE40 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEANUT OIL (UNII: 5TL50QU0W4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81877-620-04118 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/03/2023
    Labeler - FORREAL PHARMACEUTICALS LLC (118029197)
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