Label: CORALITE MEDICATED HEAT- capsaicin patch

  • NDC Code(s): 65923-123-01, 65923-123-02
  • Packager: United Exchange Corp.
  • 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 March 31, 2022

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

  • ACTIVE INGREDIENT

    Active ingredient                                                           Purpose

    Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic

  • PURPOSE

    Uses

    For temporary relief of minor aches and pains of muscles & joints associated with:

    • Simple Backache
    • Arthritis
    • Strains
    • Bruises
    • Sprains
  • 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
    • if prone to allergic reaction from aspirin or salicylates, consult a doctor before use
  • DO NOT USE

    Do not use:

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

    When using this product:

    • do not use otherwise than 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
  • 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • INDICATIONS & USAGE

    Directions

    • adults and children 12 years of age and older:
    • clean and dry affected area
    • remove patch from film
    • apply to affected area no more than 3 to 4 times daily
    • do not wear patch more than 8 hours
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    Other information

    • Avoid storing product in direct sunlight.
    • Protect product from excessive moisture.
  • INACTIVE INGREDIENT

    Inactive ingredients

    lanolin, methyl salicylate, natural rubber, peppermint oil, petrolatum, rosin, zinc oxide

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    5836 Corporate Ave.

    Cypress, CA 90630 USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    90132A

  • PRINCIPAL DISPLAY PANEL

    90198

  • INGREDIENTS AND APPEARANCE
    CORALITE MEDICATED HEAT 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN249 mg
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ROSIN (UNII: 88S87KL877)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-123-011 in 1 POUCH10/30/2018
    1249 in 1 PATCH; Type 0: Not a Combination Product
    2NDC:65923-123-022 in 1 POUCH02/10/2016
    2249 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/10/2016
    Labeler - United Exchange Corp. (840130579)