Label: REXALL ICE COLD ANALGESIC- menthol gel

  • 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 October 4, 2018

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

    Menthol 2%

  • Purpose


    Topical Analgesic

  • Uses

    For the temporary relief of monor aches and pains in muscles and joints associated with:


    ■ simple backache
    ■ sprains

    ■ arthritis

    ■ strains

    ■ sports injuries

    ■ bruises

  • Warnings

    For external use only

  • Do not use

    ■ with other topical pain relievers

    ■ with heating pads or heating devices

  • When using this product

    ■ do not use in or near eyes ■ do not apply to wounds or damaged skin ■ do not bandage tightly

  • Stop use and ask a doctor if

    ■ condition worsens ■ symptoms last for more than 7 days or clear up and occur again within a few days ■ redness or irritation develops

  • If pregnant or breast-feeding

    ask a health professional before use

  • Keep out of reach of children

    Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ clean affected area before applying product ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

  • Inactive Ingredients

    ammonium hydroxide, carbomer, cupric sulphate, FD&C blue no. 1, isopropyl alcohol, magnesium sulphate, sodium hydroxide, thymol, water

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    REXALL ICE COLD ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-088
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CUPRIC SULFATE (UNII: LRX7AJ16DT)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    THYMOL (UNII: 3J50XA376E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-088-08227 g in 1 JAR; Type 0: Not a Combination Product10/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2018
    Labeler - Dolgencorp, LLC (068331990)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!