Label: CVS PAIN RELIEF- lidocaine patch

  • Category: HUMAN OTC DRUG LABEL

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 December 1, 2017

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  • 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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