Label: DRAGON PAIN RELIEF- lidocaine 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 March 31, 2022

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

  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Lidocaine 4%................................................................Topical anesthetic

  • PURPOSE

    Use

    • 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
    • on cut, irritated or swollen skin
    • at the same as other topical analgesics
    • on puncture wounds
    • for more than one week without consulting a doctor
  • WHEN USING

    When using this product

    • use only as directed. Read and follow all directions and wanrings.
    • do not allow contact with the eyes
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • discontinue use at least 1 hour before a bath or shower
    • dispose of used patch in manner that always keep product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • irritation develops
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
  • 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
    • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
    • carefully remove smaller portion of backing from patch and apply exposed portion of 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 for up to 12 hours

    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

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Genomma Lab USA, Inc.,

    Houston, TX 77027

    Made in China

  • PRINCIPAL DISPLAY PANEL

    224

  • INGREDIENTS AND APPEARANCE
    DRAGON PAIN RELIEF 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-224
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TARTARIC ACID (UNII: W4888I119H)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-224-055 in 1 CARTON01/18/2019
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/18/2019
    Labeler - Genomma Lab USA, Inc. (832323534)