Label: BLUE GEL PAIN RELIEVING- menthol gel

  • 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 01/13

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

  • Active ingredient  

    Menthol 2%

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  • Purpose

    Analgesic

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  • Uses

    ● temporarily relieves minor aches and pains of muscles and joints associated with:

    ● arthritis ● simple backache ● strains ● sprains

    ● provides cooling penetrating relief

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  • Warnings

    For external use only

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  • Do not use

    • on wounds or damaged skin
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  • When using this product

    • avoid contact with the eyes
    • do not bandage tightly
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  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
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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

    • clean and dry skin
    • may be used with wet or dry dandages or ice packs
    • adults & children 2 years of age and older: apply to affected area not more than 3  to 4 times daily
    • children under 2 years: ask a doctor
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  • Other information

    • store at room temperature
    • keep container tightly closed
    • keep away from heat or open flame
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  • Inactive ingredients

    ammonium hydroxide, carbopol 934P, cupric sulfate monohydrate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate heptyhydrate, sodium hydroxide, thymol, water

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  • Questions or comments?

    call 1-800-645-2158

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  • Additional Information Listed on Other Panels

    Distributed by:

    Rugby Laboratories

    Livonia, MI 48150 USA

    Blue Gel

    External Analgesic

    Pain Relieving Gel

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  • Principal Display

    Blue Gel

     

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  • INGREDIENTS AND APPEARANCE
    BLUE GEL  PAIN RELIEVING
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-2302
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL .02 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CUPRIC SULFATE  
    FD&C BLUE NO. 1  
    ISOPROPYL ALCOHOL  
    MAGNESIUM SULFATE HEPTAHYDRATE  
    SODIUM HYDROXIDE  
    THYMOL  
    WATER  
    AMMONIA  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-2302-59 227 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 10/29/2012
    Labeler - Rugby Laboratories (191427277)
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