Label: EQUALINE BLUE ICE PAIN RELIEVING- menthol gel

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 October 3, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient                                                                       Purpose

    Menthol 2.0% ..........................................................................Topical Analgesic

  • PURPOSE

    Uses: Temporary relief of minor aches and pains in: Muscles and joints.

  • WARNINGS

    Warnings:

    For external use only.  Avoid contact with eyes and mucus membranes.

  • WHEN USING

    When using this product do not:

    • Use with heating pads or heating devices
    • Use, pour, spill, or store near open flame
    • Use with other creams, sprays or liniments
    • Apply to damaged skin or wounds
    • Bandage area tightly
    To do so may result in excessive skin irritation or skin burn.
  • STOP USE

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product

    and consult a physician.  If you have sensitive skin, consult a physician.  If skin irritation develops, discontinue use and seek the advice of a physician before

    using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions:

    • See important warnings under "When using this product."
    • Do not apply to children under 2 years of age, unless advised by a physician
    • Adults and children over 2 years and older: Apply liberally to painful area and massage until gel is absorbed into skin. Repeat no more than 3-4 times daily
  • INACTIVE INGREDIENT

    Inactive Ingredients: Aqua (water), Isopropyl Alcohol, Carbomer, Thymol, Ammonium Hydroxide, Sodium Hydroxide, Magnesium Sulfate, FD and C Blue No.1

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY SUPERVALU INC.

    EDEN PRAIRIE, MN 55344 USA

    MADE IN CANADA

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    EQUALINE BLUE ICE PAIN RELIEVING 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-488
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    THYMOL (UNII: 3J50XA376E)  
    AMMONIA (UNII: 5138Q19F1X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-488-32227 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34810/03/2011
    Labeler - SUPERVALU INC (006961411)
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