Label: ARCTIC ICE ANALGESIC- 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 January 27, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient:               Purpose

    Menthol, 1%  .................. Topical analgesic

  • PURPOSE

    Uses: temporarily relieves:

    • minor muscle aches and pains
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

  • INDICATIONS & USAGE

    Consult a doctor and discontinue use;

    if conditon worsens, persists for more than 1 week or tends to recur

  • WARNINGS

    Warnings: For external use only; avoid contact with eyes. Ask a doctor before use if you have associated with

    • smoking
    • excessive phlegm
    • asthma
    • emphysema
    • persisten or chronic cough

    When using this product, do; heat

    • microwave
    • add to hot water or any container where healing water may cause splatter and result in burns
    • use in eyes or directly on mucous membranes
    • take by mouth or place in nostrils
    • apply to wounds or damaged skin
    • bandage skin

  • DOSAGE & ADMINISTRATION

    Directions:

    For the temporary relief of minor muscle aches and pains. See important warnings under "When using this product"

    • not for use on children under 2 years of age
    • adults & children 2 year & older: Apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 time daily.
  • INACTIVE INGREDIENT

    Blue 1, Camphor, Carbomer, Isopropyl Alcohol, Methylchoroisothiazolinone, Methylisothiazolinone, Sodium Hydroxide, Water.

  • PRINCIPAL DISPLAY PANEL

    Arctic Ice

    Analgesic Gel

    NET WT. 8 OZ. (227)

    image description

  • INGREDIENTS AND APPEARANCE
    ARCTIC ICE ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-600-01227 g in 1 JAR; Type 0: Not a Combination Product09/16/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/16/2015
    Labeler - Blue Cross Labs (008298879)
    Registrant - Blue Cross Labs (008298879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blue Cross Labs008298879manufacture(22431-600)
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