Label: ASSURED MUSCLE RUB- menthol gel

  • NDC Code(s): 33992-1136-1
  • Packager: Greenbrier International, Inc.
  • 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 04/12

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

  • ACTIVE INGREDIENT

    Active Ingredients
    Menthol 2.5%

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  • PURPOSE

    Purpose
    Topical Analgesic

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  • INDICATIONS & USAGE

    Uses ▪ Provides soothing relief of minor arthritis pain, aching muscles, joints and backache.

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  • WARNINGS

    Warnings

    For external use only. Use only as directed.
    ▪ Avoid contact with eyes or mucous membranes. ▪ Discontinue use if excessive irritation of the skin develops. ▪ Do not bandage tightly, apply to wounds, broken or irritated skin, or use with a heating pad. ▪ If condition worsens, or if symptoms persist for more than 10 days or clear-up and occur again within a few days, if skin redness or irritation develops, discontinue use of this product and consult a doctor.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away

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  • DOSAGE & ADMINISTRATION

    Directions

    ▪ Adults and children12 years of age and older: apply to affected area not more than 3-4 times daily and gently massage until gel disappears. ▪ Children under 12 years of age: donot use, consult a doctor

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  • SPL UNCLASSIFIED SECTION

    Other Information

    ▪Store at controlled room temperature 15 to 30C (59 to 86F) ▪ Lot No. Exp. Date: see box or see crimp of tube.

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  • INACTIVE INGREDIENT

    Inactive Ingredients Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol,PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide and Water

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  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label

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  • INGREDIENTS AND APPEARANCE
    ASSURED  MUSCLE RUB
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:33992-1136
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 2.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CAMPHOR (SYNTHETIC)  
    DMDM HYDANTOIN  
    ISOPROPYL ALCOHOL  
    POLYOXYL 40 HYDROGENATED CASTOR OIL  
    SODIUM HYDROXIDE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33992-1136-1 42.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 05/15/2012
    Labeler - Greenbrier International, Inc. (610322518)
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