Label: FIRSTCARE PAIN RELIEF GEL PATCH- 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 October 25, 2019

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  • Active ingredient

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Uses

    Temporarily relieves minor pain

  • Warnings

    For external use only

    Do not use

    • more than 1 patch on your body at a time or on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor

    When using this product

    • use only as directed. Read and follow all directions and warnings on this carton.
    • do not allow contacts with the eyes
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • do not use at the same time as other topical analgesics
    • 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 ask a doctor if

    • condition worsen
    • 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

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children and pets.

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

  • Directions

    adults and children over 12 years:

    • clean and dry affected area
    • remove film from patch
    • carefully apply patch to affected area
    • use 1 patch for up to 12 hours

    children 12 years or younger: ask a doctor

  • Inactive ingredients

    polyvinyl alcohol, non-crystalizing sorbitol solution, polyacrylic acid, glycerin, carboxymethylcellulose sodium, colloidal silicon dioxide, titanium dioxide, propylene glycol, tartaric acid, magnesium hydroxide, sodium polyacrylate, purified water

  • Package/Label Principal Display Panel

    FIRST CARE TM ​

    ***MADE IN USA***

    LASTS UP TO 12 HOURS

    MAXIMUM STRENGTH**

    PAIN RELIEF GEL PATCH

    FOR BACK, SHOULDER, NECK & JOINTS


    Lidocaine 4%

    Targets Muscle and Nerve Pain

    Odor & Paraben Free


    3-15/16” x 5-1/2” (10 cm x 14 cm)

    NDC 71594-602-05

    5 PATCHES

    Individually sealed in child resistant packages

    Carton Image

  • INGREDIENTS AND APPEARANCE
    FIRSTCARE PAIN RELIEF GEL PATCH 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71594-602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE246 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SORBITOL (UNII: 506T60A25R)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TARTARIC ACID (UNII: W4888I119H)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71594-602-055 in 1 CARTON10/25/2019
    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 finalpart34810/25/2019
    Labeler - USpharma Ltd (080664601)
    Registrant - USpharma Ltd (080664601)
    Establishment
    NameAddressID/FEIBusiness Operations
    USpharma Ltd080664601manufacture(71594-602) , pack(71594-602)
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