Label: ARCTIC ICE PAIN RELIEVING- menthol gel

  • NDC Code(s): 22431-014-01, 22431-014-02
  • Packager: Blue Cross Laboratories, Inc.
  • 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 November 15, 2022

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  • ARCTIC ICE ANALGESIC GEL


  • Active Ingredient

    Menthol 2.0%

  • Purpose

    Topical Analgesic

  • Uses

    Temporary relief:

    minor muscles 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 healing 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, persist 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 and children 2 years of age and older: apply to painful area and massage until gel is absorbed into the skin, repeat 3 to 4 times daily
  • Inactive Ingredients

    blue 1, camphor, carbomer, isopropyl alcohol, methylchoroisothiazolinone, methuylisothiazoline, sodium hydroxide, water

  • PRINCIPAL DISPLAY PANEL

    arctic ice

  • INGREDIENTS AND APPEARANCE
    ARCTIC ICE PAIN RELIEVING 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-014
    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
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-014-011 in 1 PACKAGE02/23/2017
    1227 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:22431-014-021 in 1 PACKAGE11/11/2020
    2198 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/23/2017
    Labeler - Blue Cross Laboratories, Inc. (008298879)
    Registrant - Ningbo Liyuan Daily Chemical Products Co., Ltd (530766098)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd530766098manufacture(22431-014)
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