Label: CORALITE BLUE ICE- 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 5, 2016

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  • ACTIVE INGREDIENT

    Active ingredient                                                   Purpose

    Menthol 2%........................................................Topical analgesic   

  • PURPOSE

    Uses

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

    Warnings 

    For external use only

  • DO NOT USE

    Do not use

    • with other topical pain relievers
    • with heating pads or heating devices
  • WHEN USING

    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

    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
  • PREGNANCY 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    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
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

    ammonium hydroxide, carbomer 940, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate heptahydrate, purified water, sodium hydroxide, thymol

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 U.S.A.

    www.ueccorp.com

    Toll Free: 1 800 814 8028

    Made in China

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CORALITE BLUE ICE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-157
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CUPRIC SULFATE (UNII: LRX7AJ16DT)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-157-27227 g in 1 JAR; Type 0: Not a Combination Product10/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/05/2016
    Labeler - United Exchange Corp. (840130579)
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