Label: ARCTIC ICE- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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  • Active Ingredient:

    Menthol, 1.25%

  • Purpose

    Topical analgesic

  • Uses:

    temporarily relieves:

    minor muscle aches and pains

  • Warnings:

    For external use only; avoid contact with eyes.

    Ask a doctor before use if you have cough associated with smoking, excessive phlegm, asthma, emphysema, persistent or chronic cough.

  • When using this product, do not:

    heat

    microwave

    add to hot water or any container where heating water may cause splattering 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

  • Consult a doctor and discontinue use:

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

  • Keep out of reach of children.

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

  • 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 years & older: Apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.
  • Inactive Ingredients:

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

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ARCTIC ICE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80801-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER 934 (UNII: Z135WT9208)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80801-105-01198 g in 1 JAR; Type 0: Not a Combination Product10/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/01/2023
    Labeler - PRIMAL ELEMENTS (968334144)
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