Label: FRICCILICONT - menthol and methyl salicylate cream 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/12

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

  • Active ingredients

    Menthol 3%

    Methyl Salicylate 10%

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  • Purpose

    Counterirritant

    Counterirritant

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  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
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  • Warnings

    For external use only. Avoid contact with the eyes.

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  • When using this product

    do not apply to wounds or damaged skin

    do not bandage tightly

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  • Stop use and ask a doctor

    condition worsens, or if symptoms persist for more than 7
    days or clear up and occur again within a few days

    redness is present

    excessive irritation of the skin develops

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  • If pregnant or breast-feeding

    ask a health professional before use.

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  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily.

    Children under 2 years of age: Consult a physician.

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  • Inactive Ingredients

    stearic acid, turpentine, water

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  • PRINCIPAL DISPLAY PANEL

    SHAKE
    DO NOT DRINK

    Ointment

    Friccilicont
    EXTERNAL ANALGESIC
    EFFECTIVE AND REINFORCED

    LABOCONT
    INDUSTRIAL
    Sto. Dgo., Rep. Dom.

    LABORATORIOS, C. x A.

    Made In Dominican Republic

    Net Wt 10 oz (284 g)

    MADE IN DOMINICAN REPUBLIC

    MANUFACTURED FOR LABOCONT INDUSTRIAL, Km 19, Autopista las Americas, La Caleta. Sto. Dgo
    DOMINICAN REPUBLIC   TO REPORT A SERIOUS ADVERSE EVENT CONTACT 8109-756-7371

    friccilicont

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  • INGREDIENTS AND APPEARANCE
    FRICCILICONT 
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53038-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 3 g  in 100 g
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 10 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID  
    TURPENTINE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53038-001-10 284 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/15/2012
    Labeler - Labocont Industrial (871485509)
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