Label: ASSURED ICE COLD TOPICAL ANALGESIC - menthol gel

  • NDC Code(s): 33992-7994-8
  • Packager: Greenbrier International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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  • ASSURED ICE COLD TOPICAL ANALGESIC GEL
  • Active Ingredient

    Menthol 1.25%

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  • Purpose

    Topical Analgesic

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  • Uses

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

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  • 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
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  • 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
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  • Consult a doctor and discontinue use

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

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  • Keep out of reach of children.

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

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  • 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.
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  • Other information

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


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  • Inactive Ingredients

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

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  • PRINCIPAL DISPLAY PANEL

    Assured ICE COLD

    Topical Analgesic Gel

    Net wt 8oz (227g)



    DISTRIBUTED BY:

    GREENBRIER INTERNATIONAL, INC.

    CHESAPEAKE, VA 23320

    MADE IN CHINA

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  • ASSURED ICE COLD TOPICAL ANALGESIC GEL 8oz (33992-7994-8)
  • INGREDIENTS AND APPEARANCE
    ASSURED ICE COLD TOPICAL ANALGESIC  
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:33992-7994
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 1.25 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CAMPHOR (NATURAL)  
    ALCOHOL  
    FD&C BLUE NO. 1  
    ISOPROPYL ALCOHOL  
    METHYLCHLOROISOTHIAZOLINONE  
    SODIUM HYDROXIDE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33992-7994-8 227 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 07/06/2011
    Labeler - Greenbrier International, Inc. (610322518)
    Registrant - Ningbo Unichem Household Products Co., Ltd. (528196956)
    Establishment
    Name Address ID/FEI Business Operations
    Ningbo Unichem Household Products Co., Ltd. 528196956 manufacture(33992-7994)
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