Label: AMAR ICE- menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 April 14, 2011

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Menthol 2.5%

  • Purpose

    Topical analgesic

  • Uses

    • temporarily relieves minor aches and pains of muscles and joints associated with:
      • arthritis
      • bruises
      • simple backache
      • sport injuries
      • strains
      • sprains
    • provides cooling penetrating relief
  • Warnings

    For external use only

    Do not use

    • with heating pads or heating devices

    When using this product

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

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last 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. 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
    • children under 2 years of age: ask a doctor
  • Other information

    • store in a cool place
    • keep lid tightly closed
    • do not use, pour, spill or store near heat or open flame
  • Inactive ingredients

    Water, Camphor, Carbopol, Methyl Paraben Sodium, Propyl Paraben Sodium, Wintergreen oil, Propylene Glycol, Phenoxy ethanol, ISO Propyl alcohol, Sodium Hydroxide, Cl 42090.

  • PRINCIPAL DISPLAY PANEL - 227 g Jar Label

    Amar

    ICE GEL

    Net Wt 8 oz (227g)

    Principal Display Panel - 227 g Jar Label
  • INGREDIENTS AND APPEARANCE
    AMAR ICE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41499-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Camphor (Synthetic) (UNII: 5TJD82A1ET) 0.7 g  in 100 g
    MethylParaben Sodium (UNII: CR6K9C2NHK)  
    PropylParaben Sodium (UNII: 625NNB0G9N)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Propyl Alcohol (UNII: 96F264O9SV)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41499-123-01227 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2010
    Labeler - AMAR REMEDIES LIMITED (677141751)
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

More Info on this Drug

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