TOPCARE PAIN RELIEF PATCHES (LIDOCAINE) PATCH [TOPCO ASSOCIATES, LLC]

TOPCARE PAIN RELIEF PATCHES (LIDOCAINE) PATCH [TOPCO ASSOCIATES, LLC]
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NDC 36800-156-05
Set ID fa2f7768-e779-4409-aad3-6c33ce2e6b36
Category HUMAN OTC DRUG LABEL
Packager TOPCO ASSOCIATES, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Active Ingredients

    Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

  • Purpose

    Temporarily relieves minor pain.

  • Dosage and Administration

    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 one patch for up to 12 hours. Children under 12 years of age: consult a physician.

  • Warnings

    For external use only.

  • Idications and Usage

    Uses: Temporaily relieves minor pains.

  • When using this product

    ■ use only as directed

    ■ read and follow all directions and warnings on this carton

    ■ do not allow contact with the eyes

    ■ do not use at the same time as other topical analgesics

    ■ do not bandage tightly or apply local heat (such as heating pads) to the area of use

    ■ do not microwave

    ■ dispose of used patch in manner that always keeps product away from children and 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 and consult a doctor

    ■ condition worsens

    ■ redness is present

    ■ irritation develops

    ■ symptoms persist for more than 7 days or clear up and occur again within a few days

    ■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

  • PREGNANCY OR BREAST FEEDING

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

  • Do not Use

    ■ more than one patch on your body at a time

    ■ on cut, irritated or swollen skin

    ■ on puncture wounds

    ■ for more than one week without consulting a doctor

    ■ if you are allergic to any active or inactive ingredients

    ■ if pouch is damaged or opened.

  • Keep out of reach of children and pets.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Other Safety Information

    Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

  • Inactive Ingredients

    Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol,
    Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

  • Questions

    TOLL-FREE

    Customer Care Help Line
    1-888-423-0139
    Mon–Fri 8:30 am–4:30 pm CST

    DIST. BY
    TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007
    www.topcarebrand.com


    Made in China

  • PRINCIPAL DISPLAY PANEL

    labelLidocaine  Patch

  • INGREDIENTS AND APPEARANCE
    TOPCARE PAIN RELIEF PATCHES 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-156
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM (UNII: CPD4NFA903)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-156-055 in 1 CARTON07/01/2017
    19 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:36800-156-066 in 1 CARTON09/01/2021
    29 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2017
    Labeler - TOPCO ASSOCIATES, LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(36800-156)

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