Label: ASSURED ICE COLD TOPICAL ANALGESIC- camphor, 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 July 6, 2011

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  • Active Ingredients

    Camphor 3.0%

    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

    carbomer, 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

  • PRINCIPAL DISPLAY PANEL

    Ice Cold Analgesic Gel

  • INGREDIENTS AND APPEARANCE
    ASSURED ICE COLD TOPICAL ANALGESIC 
    camphor, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-7993
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.0 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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:33992-7993-8227 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)
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