Home > Drugs A-Z > Ice Cold Topical Analgesic Gel

Ice Cold Topical Analgesic Gel (Greenbrier International, Inc.)

Available Formats

Dosage Form Package Information Links
GEL 237 mg in 1 BOTTLE (33992-3007-1) Label Information

Complete Ice Cold Topical Analgesic Gel Information

  • ACTIVE INGREDIENT

    Active Ingredient                                   Purpose

    Menthol 1.25%...........................Topical Analgesic


  • PURPOSE

    Uses

    forthe temporary relief of minor aches and pains of muscles and joints.


  • KEEP OUT OF REACH OF CHILDREN

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


  • INDICATIONS & USAGE

    Other information

    • store at 20oC to 25oC (68o to 77oF)

  • WARNINGS

    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
    • microwafe
    • 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 worsesn, persists for more than 1 week or tends to recur.


  • DOSAGE & ADMINISTRATION

    Directions

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.


  • INGREDIENTS AND APPEARANCE
    ICE COLD TOPICAL ANALGESIC GEL 
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-3007
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.84 mg  in 227 mg
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33992-3007-1 237 mg in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 05/24/2013
    Labeler - Greenbrier International, Inc. (610322518)
    Establishment
    Name Address ID/FEI Business Operations
    China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture(33992-3007)