CVS PAIN RELIEF (LIDOCAINE) PATCH [NATURAL ESSENTIALS, INC.]

CVS PAIN RELIEF (LIDOCAINE) PATCH [NATURAL ESSENTIALS, INC.]
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NDC 66902-203-05
Set ID e28fa0b1-5654-4871-b748-4a6044869c8f
Category HUMAN OTC DRUG LABEL
Packager NATURAL ESSENTIALS, INC.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Active ingredient

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Use

    For the temporary relief of 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 contact 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 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

    If pregnant or breast feeding ask a physician before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults/children 12 years and older

    • 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

  • Other information

    Store at room temperature - do not exceed 86° Fahrenheit, 30° Celsius.

  • Inactive ingredients

    Benzyl Alcohol, Carboxymethylcellulose Sodium, Dihydroxyaluminium Aminoacetate, Glycerin, Kaolin, Partially Neutralized Polyacrylate, Polysorbate 80, Polyvinyl Pyrrolidone 90, Propylene Glycol, Tartaric Acid, Tetrasodium Edetate, Titanium Dioxide, Urea, Water.

  • Principal Display Panel - Carton Label

    CVS Health™

    Compare to the active ingredient in Aspercreme® Lidocaine Patch*

    MAXIMUM STRENGTH

    NDC 66902-203-05

    Pain Relief
    Patch

    UP TO 12 HOURS

    ODOR FREE

    LIDOCAINE 4%

    • Desensitizes aggravated nerves
    • Fast acting
    • Easy to apply
    • No irritation or burning

    Topical Anesthetic

    Package Contains 5 Individually Wrapped Patches

    5 PATCHES

    3 5/16" x 5 1/2" (10 cm x 14 cm)

    Figure
  • Principal Display Panel - Pouch Label

    CVS Health™

    Compare to the active ingredient in Aspercreme® Lidocaine Patch*

    MAXIMUM STRENGTH

    NDC 66902-203-05

    Pain Relief
    Patch

    UP TO 12 HOURS

    ODOR FREE

    LIDOCAINE 4%

    • Desensitizes aggravated nerves
    • Fast acting
    • Easy to apply
    • No irritation or burning

    Topical Anesthetic

    1 PATCH

    3 5/16" x 5 1/2" (10 cm x 14 cm)

    Figure
  • INGREDIENTS AND APPEARANCE
    CVS PAIN RELIEF 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-203
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TARTARIC ACID (UNII: W4888I119H)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-203-055 in 1 BOX12/01/2017
    11 in 1 POUCH
    11 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2017
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-203)

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