Label: ICE QUAKE- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 September 4, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol 15%

  • PURPOSE

    Topical analgesic

  • Uses

    temporarily relieves minor pain associated with:

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

    For external use only.

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes or mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
    • if severe burning sensation occurs, discontinue use immediately
    • do not expose the area treated with product to heat or direct sunlight.

    Stop use and ask a doctor if:

    • condition worsens
    • redness is present
    • irritation develops

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

  • Directions

    adults and children over 18 years:

    • apply to affected area
    • squeeze desired amount of ICEQUAKE onto affected area
    • massage dispensed gel into painful area until thoroughly absorbed
    • repeat as necessary, but no more than 3 to 4 times daily.
    • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER
  • Inactive Ingredients

    HPMC, Glycerine, FD&C blue #1, Carbopol, Isopropyl alcohol, Propylene glycol, Methylparaben, Sodium hydroxide, Purified water.

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY:
    GADAL Laboratories, Inc.• Miami, FL 33186

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Label

    ICEQUAKE
    Pain Relieving GEL
    Menthol
    15%

    Net wt 4 oz (113 g)

    Principal Display Panel - 113 g Tube Label
  • INGREDIENTS AND APPEARANCE
    ICE QUAKE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol16.95 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Glycerin (UNII: PDC6A3C0OX)  
    FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
    Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-100-01113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34808/23/2012
    Labeler - Gadal Laboratories, Inc. (841305639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gadal Laboratories, Inc.841305639MANUFACTURE(53113-100)
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