Label: NATURES CHOICE COOL HOT 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 September 8, 2014

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

View All Sections
  • Active Ingredient

    Active Ingredients                                                      Purpose

    Menthol 2%..................................................External Pain Reliever

  • Purpose

    External Pain Reliever

  • Uses

    Temporarily relief of minor pains of muscles and joints associated with - simple back ache - arthritis - sprains, strains, or bruises

  • Warnings

    Warnings

    For external  use only.  Avoid contact with eyes

  • Do not use

    Do not use - internally - with heating pad or devices - on wounds or damaged skin

  • Ask a doctor before use

    Ask doctor before use if you have sensitive skin

  • When using this product

    When using this product - Use only as directed - do not bandage tightly - avoid contact with eyes and mucus membranes

  • If pregnant or breast-feeding

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children

    Keep out of reach of children.  In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    -Adult and children 2 years of age and older.  Clean skin thoroughly.  Apply liberally to affected area no more than 3-4 times daily.  No protective cover needed.

    -May be used with ice packs

    -May be used with wet or dry bandages, but wrap loosely

    -Children under 2 years of age, consult a doctor

  • Other information

    Other information store between 59o - 86oF (15o - 30oC)

    Keep tightly closed

    Do not use, pour, spill, or store near heat or open flame

  • Other ingredients

    Camphor, Carbomer 940, FDC Blue #1, Isopropyl alcohol, Propylene glycol, Purified water, Sodium hydroxide

  • Product Label

    Product Label

  • INGREDIENTS AND APPEARANCE
    NATURES CHOICE COOL HOT ICE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-320
    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
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43749-320-08226 g in 1 JAR09/18/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/18/2014
    Labeler - Unipack, Inc. (009248480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(43749-320)
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!