DRAGON PAIN RELIEF (LIDOCAINE) PATCH [GENOMMA LAB USA, INC.]

DRAGON PAIN RELIEF (LIDOCAINE) PATCH [GENOMMA LAB USA, INC.]
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NDC 50066-224-05
Set ID 7fc18caf-cf4a-cdd0-e053-2991aa0a1be9
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab USA, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • 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)

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