Label: CVS HEALTH LIDOCAINE PAIN-RELIEVING- lidocaine kit

  • NDC Code(s): 66902-270-01, 66902-270-02, 66902-270-03, 66902-450-06
  • Packager: NATURAL ESSENTIALS, INC.
  • 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 January 6, 2023

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  • Active ingredient

    Lidocaine 4%

  • Purpose

    Topical Analgesic

  • 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 use more than one patch in an 8 hour period. Maximum 3 patches per day.
    • Rare cases of serious burns have been reported with products of this type
    • Do not apply to wounds or damaged, broken or irritated skin
    • Do not allow contact with the eyes and mucous membranes
    • 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 products that can produce serious adverse effects if a child or pet chews or ingests this patch
    • NOTE: patches may not adhere as well to all individuals, skin types, or certain parts of the body.

    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 completely to apply patch to affected area
    • once applied, press firmly and rub on all sides and center of patch to help adhesive adhere to skin
    • do not remove patch and reapply, this will result in the patch not sticking a avoid strenuous exercise while wearing patch, this will result in patch not sticking
    • do not use more than one patch in an 8 hour period.

    Children 12 years or younger: ask a doctor.

  • Other information

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

  • Inactive ingredients

    aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, povidone, sodium polyacrylate, tartaric acid, titanium dioxide, water

  • Principal Display Panel – Small Patch Label

    CUT OPEN POUCH AND REMOVE PATCH

    CVS
    Health®

    Compare to the active ingredient in
    Salonpas® 4% Lidocaine Gel Patch*

    MAXIMUM STRENGTH

    Lidocaine concentration without a prescription†

    Lidocaine
    Pain-Relieving
    Patch

    LIDOCAINE 4% GEL

    Desensitizes aggravated nerves

    • Fast acting
    • Easy to apply
    • No irritation or burning

    Unscented

    †Among over the counter
    topical analgesics.

    1 PATCH | SMALL

    3 1/8” x 4 3/4” (8 cm x 12 cm)

    Principal Display Panel – Small Patch Label
  • Principal Display Panel – Medium Patch Label

    CUT OPEN POUCH AND REMOVE PATCH

    CVS
    Health®

    Compare to the active ingredient in
    Salonpas® 4% Lidocaine Gel Patch*

    MAXIMUM STRENGTH

    Lidocaine concentration without a prescription†

    Lidocaine
    Pain-Relieving
    Patch

    LIDOCAINE 4% GEL

    Desensitizes aggravated nerves

    • Fast acting
    • Easy to apply
    • No irritation or burning

    Unscented

    †Among over the counter
    topical analgesics.

    1 PATCH | MEDIUM

    3 15/16” x 5 1/2” (10 cm x 14 cm)

    Principal Display Panel – Medium Patch Label
  • Principal Display Panel – X Large Patch Label

    CUT OPEN POUCH AND REMOVE PATCH

    CVS
    Health®

    Compare to the active ingredient in
    Salonpas® 4% Lidocaine Gel Patch*

    MAXIMUM STRENGTH

    Lidocaine concentration without a prescription†

    Lidocaine
    Pain-Relieving
    Patch

    LIDOCAINE 4% GEL

    Desensitizes aggravated nerves

    • Fast acting
    • Easy to apply
    • No irritation or burning

    Unscented

    †Among over the counter
    topical analgesics.

    1 PATCH | X LARGE

    5 1/2” x 9 7/8” (14 cm x 25 cm)

    Principal Display Panel – X Large Patch Label
  • Principal Display Panel – Carton Label

    CVS
    Health®

    Compare to the active
    ingredients in Salonpas®
    4% Lidocaine Gel Patch*

    MAXIMUM STRENGTH

    Lidocaine concentration
    without a prescription    †

    Lidocaine
    Pain-Relieving
    Patches

    LIDOCAINE 4% GEL

    Desensitizes
    aggravated nerves

    • Fast acting
    • Easy to apply
    • No irritation or burning

    Unscented

    6 ASSORTED SIZE PATCHES

    2 SM 3 1/8” x 4 ¾” (8 cm x 12 cm)

    2 MED 3 15/16” x 5 1/2” (10 cm x 14 cm)

    2 XL 5 1/2” x 9 7/8” (14 cm x 25 cm)

    ASSORTED
    SIZES

    Principal Display Panel – Carton Label
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH LIDOCAINE PAIN-RELIEVING 
    lidocaine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-450
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-450-061 in 1 CARTON; Type 0: Not a Combination Product06/02/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 PATCH 14 g
    Part 22 PATCH 22 g
    Part 32 PATCH 46 g
    Part 1 of 3
    CVS HEALTH LIDOCAINE PAIN-RELIEVING 
    lidocaine patch
    Product Information
    Item Code (Source)NDC:66902-270
    Route of AdministrationTRANSDERMAL
    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)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-270-012 in 1 NOT APPLICABLE
    17 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 finalpart34806/02/2020
    Part 2 of 3
    CVS HEALTH LIDOCAINE PAIN-RELIEVING 
    lidocaine patch
    Product Information
    Item Code (Source)NDC:66902-270
    Route of AdministrationTRANSDERMAL
    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)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-270-022 in 1 NOT APPLICABLE
    111 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 finalpart34806/02/2020
    Part 3 of 3
    CVS HEALTH LIDOCAINE PAIN-RELIEVING 
    lidocaine patch
    Product Information
    Item Code (Source)NDC:66902-270
    Route of AdministrationTRANSDERMAL
    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)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-270-032 in 1 NOT APPLICABLE
    123 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 finalpart34806/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/02/2020
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech, Co., Ltd.529128763MANUFACTURE(66902-450, 66902-270)
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