PAIN RELIEF LIDOCAINE (LIDOCAINE) PATCH [FAMILY DOLLAR]

PAIN RELIEF LIDOCAINE (LIDOCAINE) PATCH [FAMILY DOLLAR]
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NDC 55319-959-01
Set ID 75502ecb-15ae-15aa-e053-2991aa0a5acb
Category HUMAN OTC DRUG LABEL
Packager FAMILY DOLLAR
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Lidocaine 4%.................................................... Topical anesthetic

  • PURPOSE

    Use
    ■ temporarily relieves minor pain

  • WARNINGS

    For external use only

  • DO NOT USE

    Do not use
    ■ more than 1 patch on your body at a time or on cut, irritated or
    swollen skin ■ at the same time 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
    warnings 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
    ■ discontinue use at least 1 hour before a bath or shower
    ■ do not use immediately after a bath or shower
    ■ dispose of used patch in manner that always keeps 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:
    MIDWOOD BRANDS, LLC
    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 USA

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    49569.1

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF LIDOCAINE 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-959
    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
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALCOHOL (UNII: 3K9958V90M)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-959-011 in 1 POUCH09/07/2018
    10.04 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 finalpart34809/07/2018
    Labeler - FAMILY DOLLAR (024472631)

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