Label: ASSURED ICE COLD TOPICAL ANALGESIC- 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 March 27, 2013

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  • ASSURED ICE COLD TOPICAL ANALGESIC GEL


  • Active Ingredient

    Menthol 1.25%

  • Purpose

    Topical Analgesic

  • Uses

    for the temporary relief of minor aches and pains of muscles and joints

  • 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

    • see important warnings under "When using this product"
    • adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a physician.
  • Other information

    store at 20 to 25 degreesC (68 to 77degrees F)


  • Inactive Ingredients

    camphor, carbomer, ethyl alcohol, FDandC blue no.1, isopropyl alcohol, methylchloroisothiasolinone, methylisothiazolinone, sodium hydroxide, water.

  • PRINCIPAL DISPLAY PANEL

    Assured ICE COLD

    Topical Analgesic Gel

    Net wt 8oz (227g)



    DISTRIBUTED BY:

    GREENBRIER INTERNATIONAL, INC.

    CHESAPEAKE, VA 23320

    MADE IN CHINA

  • ASSURED ICE COLD TOPICAL ANALGESIC GEL 8oz (33992-7994-8)

    ICECOLD

  • INGREDIENTS AND APPEARANCE
    ASSURED ICE COLD TOPICAL ANALGESIC  
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-7994
    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
    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:33992-7994-8227 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/06/2011
    Labeler - Greenbrier International, Inc. (610322518)
    Registrant - Ningbo Unichem Household Products Co., Ltd. (528196956)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Unichem Household Products Co., Ltd.528196956manufacture(33992-7994)
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