Active Ingredient
Lidocaine 4%
Menthol 3%
Tidl Pain Relief Numbing Patch
FDA Label NDC 83822-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fuzhou Ayimong Trading Co., Ltd. for the product Tidl Pain Relief Numbing Patch (NDC 83822-003). 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, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Use
for the temporary relief of pain
Warnings
For external use only
Do Not Use
·on puncture wounds,cuts,irritated,damaged or swollwn skin
·more than 1 patch on your body at a time or with other topical analgesics at the same time
·with a heating pad or apply local heat to the area of use
When Using
·use only as directed
·do not bandage tightly
·avoid contact with eyes and mucous membranes
·rare cases of serious burns have been reported with products of this type
·a transient burning sensation may occur upon application but generally disappears in several days
·dispose of used patch in manner that always keeps products 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
·condition worsens or symptoms persist for more than 7 days
·symptoms clear up and occur again within a few days
·severe burning sensation,redness or irritation develops
·you experience signs of skin injury,such as pain,swelling,or blistering where the product was applied
Ask Doctor
·condition worsens or symptoms persist for more than 7 days
·symptoms clear up and occur again within a few days
·severe burning sensation,redness or irritation develops
·you experience signs of skin injury,such as pain,swelling,or blistering where the product was applied
Keep Oot Of Reach Of Children
If swallowed, get medical help or contact a poison control center right away.
Directions
Adults and children 12 years of age and older:
-clean and dry affected area
-remove backing from patch by firmly grasping both ends and gently pulling until backing seprarates in middle
-carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
-once exposed portion of the 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
Children under 12 years of age: consult a doctor
Inactive Ingredients
Aluminum glycinate, chili extract, EDTA-2NA, ethanol, glycerol, sodium polyacrylate, tartaric acid,
water, wintergreen oil
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