Label: DT ICE COLD ANALGESIC- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 3, 2015

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  • ACTIVE INGREDIENT

    DRUG FACTS

    Active ingredients                        Purpose

    Menthol (1%)................................Topical Analgesic

  • PURPOSE

    Purpose
    topical analgesic

  • INDICATIONS & USAGE

    Uses-

    temporarily relieves:minor muscle aches and pains

  • WARNINGS

    Warnings

    For external use only; avoid contact with eyes.

  • ASK DOCTOR

    Ask a doctor before use if you have cough associated with
    smoking
    excessive phlegm
    asthma
    emphysema
    persistent or chronic cough

  • WHEN USING

    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.

  • STOP USE

    Consult a doctor and discontinue use;
    if condition worsens, persists for more than 1 week or tends to recur.

  • 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

  • DOSAGE & ADMINISTRATION

    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 y ears and older: apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Camphor, Carbomer, FDandC Blue No1, Isopropyl Alcohol, methylchloroisothiazolinone, methylisothiazolinone, Sodium hydroxide, water.

  • PRINCIPAL DISPLAY PANEL

    DT ICE COLD
    ANALGSIC GEL

    Distributed by:
    DT products
    Vernon,CA 90058
    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    Ice Cold Analgesic

  • INGREDIENTS AND APPEARANCE
    DT ICE COLD ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50523-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50523-000-08227 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/22/2010
    Labeler - Volume Distributors, Inc. (002029544)
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