Label: BELLADONA- methyl salicylate, menthol ointment

  • NDC Code(s): 79974-209-05
  • Packager: Miramar Cosmetics, Inc DBA Miramar Lab
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients

    Methyl Salicylate 10%
    Menthol 3.5%

  • Purpose

    Topical Analgesic

  • Uses:

    *Helps relieve minor aches and pain of muscles, joints, strains, backache, sprains, and sport injuries.

  • Warnings:

    For external use only.

    Do not Use:
    • If allergic to salicylates (including aspirin) without consulting a physician.
    • On open wounds, damage or irritated skin, immediately after or before taking a shower.

    Stop use and ask a Doctor: If conditions worsen, symptoms persist or skin irritations occurs.

    When using this product: Avoid contact with eyes, lips and any mucous membranes.

    Keep out of reach of children. 
    If swallowed get medical help. Do not bandage.

  • Directions:

    Clean area before use.
    Adults & Children 12 years of age or older: Apply to affected area no more than 3 times daily. Temporary burning may be felt when applied, but disappears with continued use.
    Wash hands after used. If applying liniment to the hands wait 30 minutes before washing hands. Initial pain relief is noted within 1-2 weeks.

    Children under 12 years: Consult a Physician before use.

  • Other Information:

    Store at 15-25° C (59-77° F)

  • Inactive Ingredients:

    White Petrolatum, Soybean Oil, Belladonna extract, Green MX-144A.

  • SPL UNCLASSIFIED SECTION

    MADE IN USA
    SATISFACTION GUARANTEED QUALITY

    *These statements have not been evaluated by the Food and Drug Administration.
    This product is not intended to diagnose, treat, cure or prevent any disease.

    Distributed by:
    OTC & Quality Products
    Orlando, FL 32837

    InfoLine:
    1-877-325-7887

    www.otcqualityproducts.com

  • Packaging

    Miramar-209

  • INGREDIENTS AND APPEARANCE
    BELLADONA 
    methyl salicylate, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79974-209
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM3.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    BELLADONNA LEAF (UNII: 6GZW20TIOI)  
    D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
    D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79974-209-05150 g in 1 JAR; Type 0: Not a Combination Product01/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/08/2024
    Labeler - Miramar Cosmetics, Inc DBA Miramar Lab (012873243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Miramar Cosmetics, Inc DBA Miramar Lab012873243manufacture(79974-209)