Otc - Active Ingredient
Active ingredient Purpose
Lidocaine 4%..............................................................Topical anesthetic
Cvs 9083 Maximum Strength Lidocaine 4 Pain Relief Patch 1ct Large Patch
FDA Label NDC 51316-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Cvs 9083 Maximum Strength Lidocaine 4 Pain Relief Patch 1ct Large (NDC 51316-100). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use
temporarily relieves minor pain
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use
more than 1 patch on your body at a time
at the same time as other topical analgesics
on damaged skin, or puncture wounds
for more than one week without consulting a doctor
if you are allergic to any ingredients of this product
Otc - When Using
When using this product
use only as directed. Read and follow all directions and warnings on
this label.
do not allow contact with the eyes
do not bandage tightly or apply local heat (such as heating pads) to
the area of use
avoid the patch getting wet for better adhesion
dispose of used patch in manner that always keeps product away
from children or pets. Used patches still contain enough lidocaine to
cause serious or life-threatening problems.
Otc - Stop Use
Stop use and ask a doctor if
skin reactions occur, such as pain, swelling, rash, redness, itching,
irritation, or blistering where the product was applied
symptoms persist for more than 7 days or clear up and occur again
within a few days
condition worsens
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional 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 (1-800-222-1222) right away.
Indications & Usage
Directions
adults and children over 12 years:
clean and dry affected area
expose a portion of the patch by firmly grasping an edge or corner
and gently pull apart until backing separates
position and apply exposed portion of the 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 at a time and not more than 3 to 4 times daily
wash hands after applying or removing patch
throw away the patch by folding sticky ends together
children 12 years or younger: ask a doctor
Storage And Handling
Other information
store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
alcohol, aluminum glycinate, glycerin, kaolin, methylparaben,
polysorbate 80, propylparaben, purified water, sodium polyacrylate
(2500000 MW), tartaric acid, titanium dioxide
Dosage & Administration
Questions or comments?
Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
2026 CVS/pharmacy
CVS.com 1-800-SHOP CVS
Made in China
* Please review the disclaimer below.
