Cvs Health Xl Lidocaine Pain Relief Patch
FDA Label NDC 66902-286

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Essentials, Inc. for the product Cvs Health Xl Lidocaine Pain Relief (NDC 66902-286). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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 or 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 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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a physician before use.

Otc - Keep Out Of Reach Of Children

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

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
  • 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 patch not sticking
  • avoid strenuous exercise while wearing patch, this will result in patch not sticking.
  • use 1 patch for up to 12 hours

Other

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 – Box Label

CVS
Health

Compare to the active ingredient in
Aspercreme® Lidocaine Patch XL*

MAXIMUM STRENGTH

Lidocaine Pain
Relief Patch

XL

LIDOCAINE 4%

Topical anesthetic

Odor Free

  • Desensitizes
    aggravated nerves
  • Fast acting
  • Easy to apply
  • No irritation
    or burning
  • UP TO
    12
    HOURS

    3 PATCHES Individually wrapped

    4 3/4” x 7 7/8” (12 cm x 20 cm)

    Pain relieving ointment on a breathable adhesive pad

    Principal Display Panel – Box Label (Cvs0p 0000 01)

    Principal Display Panel – Box Label (Cvs0p 0000 01)

Principal Display Panel – Patch Label

CVS
Health

Compare to the active ingredient in
Aspercreme® Lidocaine Patch XL*

MAXIMUM STRENGTH

Lidocaine Pain
Relief Patch

XL

LIDOCAINE 4%

Topical anesthetic

Odor Free

  • Desensitizes
    aggravated nerves
  • Fast acting
  • Easy to apply
  • No irritation
    or burning
  • UP TO
    12
    HOURS

    1 PATCH

    4 3/4” x 7 7/8” (12 cm x 20 cm)

    Pain relieving ointment on a breathable adhesive pad

    Principal Display Panel – Patch Label (Cvs0p 0000 02)

    Principal Display Panel – Patch Label (Cvs0p 0000 02)

* Please review the disclaimer below.