Label: ICE COLD TOPICAL ANALGESIC GEL- menthol gel

  • NDC Code(s): 58503-007-01
  • Packager: China Ningbo Shangge Cosmetic Technology Corp.
  • 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 November 17, 2022

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  • 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.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    ICE COLD TOPICAL ANALGESIC GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.84 mg  in 227 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-007-01237 mg in 1 BOTTLE; Type 0: Not a Combination Product05/24/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/24/2013
    Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-007)
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