Cvs Health Lidocaine Pain-relieving Kit
FDA Label NDC 66902-450

17 label sections · Submitted to the FDA by Natural Essentials, Inc. · 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 Lidocaine Pain-relieving (NDC 66902-450). 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 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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feedingask 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.

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.

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 – 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

    6ASSORTED 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)

    Pain-relieving ointment on a breathable adhesive pad

    EACH PATCH IS SEALED IN A CHILD-RESISTANT POUCH FOR SAFETY

    ASSORTED
    SIZES

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.

    1PATCH | SMALL

    3 1/8” x 4 3/4” (8 cm x 12 cm)

    Lidocaine Patch Small (450467 Licocane Patch Assort 6ct 8x12 Pouch 1 5 2024 Min)

    Lidocaine Patch Small (450467 Licocane Patch Assort 6ct 8x12 Pouch 1 5 2024 Min)

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.

    1PATCH | MEDIUM

    3 15/16” x 5 1/2” (10 cm x 14 cm)

    Lidocaine Patch Medium (450467 Licocane Patch Assort 6ct 10x14 Pouch 1 5 2024 Min)

    Lidocaine Patch Medium (450467 Licocane Patch Assort 6ct 10x14 Pouch 1 5 2024 Min)

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.

    1PATCH | X LARGE

    5 1/2” x 9 7/8” (14 cm x 25 cm)

    Lidocaine Patch Xl (450467 Licocane Patch Assort 6ct 14x25 Pouch 1 5 2024 Min)

    Lidocaine Patch Xl (450467 Licocane Patch Assort 6ct 14x25 Pouch 1 5 2024 Min)

* Please review the disclaimer below.