Otc - Active Ingredient
Active ingredient Purpose
Lidocaine 4%...............................................................................Topical anesthetic
Winco Lidocaine Pain Patch 4% 5ct Patch
FDA Label NDC 67091-940
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Winco Lidocaine Pain Patch 4% 5ct (NDC 67091-940). 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 for up to 12 hours
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? Call 800-824-1706 Monday-Friday 9am - 4pm MST
Distributed By: WINCO FOODS, LLC, BOISE, ID 83704
Made in China
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