Label: CORALITE ODOR FREE PAIN RELIEF- lidocaine patch

  • NDC Code(s): 65923-149-01
  • Packager: United Exchange Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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

  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Lidocaine 4%...............................................Topical analgesic

  • PURPOSE

    Uses

    • temporarily relieves minor pain
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • more than 1 patch on your body at a time
    • at the same time as other topical analgesics
    • on damaged skin, or puncture wounds
    • for more than one week without consulting a doctor
    • if you are allergic to any ingredients of this product
  • WHEN USING

    When using this product

    • use only as directed. Read and follow all directions and warning on this label.
    • do not allow contact with the eyes
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • avoid the patch getting wet for better adhesion
    • dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain enough lidocaine to cause serious or life-threatening problems.
  • STOP USE

    Stop use and ask a doctor if

    • skin reactions occur, such as pain, swelling, rash, redness, itching, irritation, or blistering where the product was applied
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • condition worsens
  • 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 over 12 years:
    • clean and dry affected area
    • expose a portion of the patch by firmly grasping an edge or corner and gently pull apart until backing separates
    • position and apply exposed portion of the patch to affected area
    • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area.
    • use 1 patch at a time, not more than 3 to 4 times daily
    • children 12 years or younger: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments?

    Call 1-888-645-8204 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

    90159

  • INGREDIENTS AND APPEARANCE
    CORALITE ODOR FREE PAIN RELIEF 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-149
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    ALCOHOL (UNII: 3K9958V90M)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TARTARIC ACID (UNII: W4888I119H)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-149-011 in 1 POUCH10/29/2018
    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 DrugM01710/29/2018
    Labeler - United Exchange Corporation (840130579)