Label: MEDIC ICE- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 27, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol 7%
  • PURPOSE

    Purpose

    Pain relieving gel
  • KEEP OUT OF REACH OF CHILDREN

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

    Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
  • WARNINGS



    • For external use only

    Do not use

    •  on wounds or damaged skin
    • with heating pads or heating devices
    •  with other ointments, creams, sprays or liniments
    •  with tight bandages

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if:

    • a rash appears
    • condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days

    If pregnant or breast-feeding, ask a doctor before use.

  • DOSAGE & ADMINISTRATION


    Directions
    • Adults and children 2 years and over: Clean skin of all other ointments, creams, sprays or liniments.  Apply directly to affected areas no more than 3 to 4 times daily.  Wash hands after application to help avoid contact with eyes and sensitive areas. May be used with wet or dry bandages or with ice packs.
    • Children under 2 years of age:  ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients   Water, Alcohol, Laureth-4, Carbomer, Triethanolamine, Aloe Vera, Benzocaine, Thymol, Camphor, Methylsulfonylmethane (MSM), Glucosamine HCl, Chondroitin Sulfate, Oil Complex - (Oregano, Eucalyptus, Sage, Patchouli, Lavender, Rosemary, Ginger, Peppermint), Fragrance, Mineral Complex - (Magnesium Sulfate, Copper Sulfate, Calcium Sulfate, Calcium Carbonate, Lithium Chloride, Potassium Chloride, Sodium Sesquicarbonate, Ammonium Chloride), Herbal Complex - (Arnica, Slippery Elm, Chickweed, Comfrey, Myrrh, Hops, Marshmallow, Plantain, Green Tea), FD and C Blue No. 1.
  • PRINCIPAL DISPLAY PANEL

    ID:                        Med1
    Descriptive Text:   Medic Ice label
    File Name:            medicice.jpg

    Medic Ice Label


  • INGREDIENTS AND APPEARANCE
    MEDIC ICE  
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62001-0318
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.07 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    BENZOCAINE (UNII: U3RSY48JW5)  
    LAURETH-4 (UNII: 6HQ855798J)  
    THYMOL (UNII: 3J50XA376E)  
    ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ALOE (UNII: V5VD430YW9)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    PATCHOULI OIL (UNII: F3IN55X5PO)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    SAGE OIL (UNII: U27K0H1H2O)  
    OREGANO (UNII: 0E5AT8T16U)  
    GLUCOSAMINE (UNII: N08U5BOQ1K)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    LITHIUM CHLORIDE (UNII: G4962QA067)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV)  
    AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ELM (UNII: 63POE2M46Y)  
    STELLARIA MEDIA (UNII: 2H03479QVR)  
    COMFREY (UNII: D05HXK6R3G)  
    MYRRH (UNII: JC71GJ1F3L)  
    HOPS (UNII: 01G73H6H83)  
    PLANTAGO MAJOR (UNII: W2469WNO6U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62001-0318-1318880.8 g in 1 CONTAINER
    2NDC:62001-0318-2454 g in 1 CONTAINER
    3NDC:62001-0318-371 g in 1 TUBE, WITH APPLICATOR
    4NDC:62001-0318-4113 g in 1 TUBE
    5NDC:62001-0318-54 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/24/2004
    Labeler - Straight Arrow Products, Inc. (061580593)
    Registrant - Straight Arrow Products, Inc. (061580593)
    Establishment
    NameAddressID/FEIBusiness Operations
    Straight Arrow Products, Inc.061580593manufacture
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