Label: CORALITE PAIN RELIEF HOT- menthol and capsaicin patch

  • NDC Code(s): 65923-146-02
  • Packager: United Exchange Corporation
  • 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 June 4, 2021

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  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredient Purpose

    Capsicum extract 0.17 mg as Capsaicin........Topical analgesic

    Menthol 30 mg....................................................Topical analgesic

  • PURPOSE

    Uses

    temporarily relieves minor pain of muscles and joints associated with:

    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises
  • WARNINGS

    Warnings

    For external use only

    Allergy alert: Do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product.

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
  • WHEN USING

    When using this product

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly
    • discontinue use at least 1 hour before a bath or shower
    • do not use immediately after a bath or shower
  • 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 or irritation or rash develops
    • a severe burning sensation occurs
  • 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 (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • adults and children 18 years of age and older:
    • clean and dry affected area
    • remove patch from film
    • apply to affected area not more than 3 to 4 times daily
    • removed patch from the skin after 8 hours application
    • children under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
    • avoid storing product in direct sunlight
    • protect product from excessive moisture
  • INACTIVE INGREDIENT

    Inactive ingredients alcohol, aluminum glycinate, glycerin, kalin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

  • QUESTIONS

    Questions or comments?

    Call 1-800-814-8028 monday-Friday 9AM-5PM (PST)

  • DOSAGE & ADMINISTRATION

    Distributed By: UNITED EXCHANGE CORPORATION

    Cypress, CA 90630 USA | 1-888-645-8204

    Made In China

  • PRINCIPAL DISPLAY PANEL

    90152.1

  • INGREDIENTS AND APPEARANCE
    CORALITE PAIN RELIEF HOT 
    menthol and capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-146
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.83 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    TARTARIC ACID (UNII: W4888I119H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-146-022 in 1 POUCH10/23/2018
    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 finalpart34810/23/2018
    Labeler - United Exchange Corporation (840130579)
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