FDA Label for Cvs Health Lidocaine Pain Relief

View Indications, Usage & Precautions

ACTIVE INGREDIENTS
PURPOSE
USE
WARNINGS
DO NOT USE
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER
OTHER INFORMATION
INACTIVE INGREDIENTS
PRINCIPAL DISPLAY PANEL – BOX LABEL
PRINCIPAL DISPLAY PANEL – PATCH LABEL

Cvs Health Lidocaine Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Natural Essentials, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients

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.
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

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.

Directions

Adults/children 12 years and older
clean and dy 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
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*

MAXIMUM STRENGTH

Lidocaine Pain
Relief Patch

LIDOCAINE 4%

UP TO
12
HOURS

Odor Free

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

Topical analgesic

Package Contains 5 Individually
Wrapped Patches

5 PATCHES

3 15/16” x 5 1/2” (10 cm x 14 cm)

Principal Display Panel – Patch Label