Label: CORALITE COLD AND HOT- menthol patch

  • 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 July 20, 2017

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

  • ACTIVE INGREDIENT

    Active Ingredient                                            Purpose

    Menthol 5%................................................... Topical analgesic

  • PURPOSE

    Uses

    Temporarily relieves minor aches and pains of muscles and joints due to:

    • arthritis
    • simple backache
    • bursitis
    • tendonitis
    • muscle sprains
    • bruises
    • cramps
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous mebranes
    • do not apply to wounds or damaged skin
  • STOP USE

    Stop use and ask a doctor if:

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • skin 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 Poision Control Center right away
  • INDICATIONS & USAGE

    Directions

    Adults and children 12 years of age and older

    • peel off protective backing and apply sticky side to affected area
    • carefully remove backing from patch
    • should be used up to 8 hours
    • should be used no more than 3 times a day
    • children under 12 years of age: consult a doctor
  • INDICATIONS & USAGE

    Other Information

    • store at room temperature, not to exceed 86°F (30°C)
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera gel, BHT, castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydroxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminosilicate, methylparaben, PEG, monostearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    UNITED EXCHANGE CORP.

    17211 VALLEY VIEW AVE.

    CERRITOS, CA 90703 USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CORALITE COLD AND HOT 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-153
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-153-022 in 1 POUCH07/13/2017
    11 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/16/2013
    Labeler - United Exchange Corp. (840130579)