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

Drug Label Information

Updated April 11, 2024

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

    butylated hydroxytoluene, diphenhydramine, hydrochloride, glyceryl, rosinate, lanolin, natural rubber, petrolatum, polyisobutylene (85,000 MW), styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    5836 Corporate Ave.

    Cypress, CA 90630 USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    90198A

  • 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
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)  
    GLYCERYL ROSINATE (UNII: SD112V492J)  
    LANOLIN (UNII: 7EV65EAW6H)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY)  
    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 DrugM01702/10/2016
    Labeler - United Exchange Corp. (840130579)