Otc - Active Ingredient
Lidocaine 4%
Menthol 1.8%
Lidocaine Pain Relief Patches Patch
FDA Label NDC 84876-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Changsha Maocheng Trading Co., Ltd for the product Lidocaine Pain Relief Patches (NDC 84876-101). 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, inactive ingredient, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Purified water
g1 ycerol
Glucosamine
polyving akohol
Tartaric acid
Disodium edetate dihydrate
Aluminium glycinat
Sodium polyacrylate
Otc - Purpose
Temporarily relieves minor aches and pains of muscles and joints associated with:
msimple backache marthritis mstrains mbruises msprains
Warnings
WarningsFor external use only.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets. lf swallowed, get medical help or contacta Poison Control Center(1-800-222-1222)right away.
Indications & Usage
Directions
Adults and children 12 years of age and over: Clean and dry affected area,free of lotions, ointments and creams.Carefully remove backing starting at a corner.Apply sticky side of patch to affected area. Do not use more than onepatch in a 12 hourperiod. Repeat as necessary. Maximum 2 patches per day. Discard patch after singleuse.Children under 12 years of age: consult a physician.
Dosage & Administration
Maximum 2 patches per day. Discard patch after singleuse.Children under 12 years of age: consult a physician.
Other Safety Information
Otherinformation
Store in a clean, dry place outside of direct sunlight, Protect from excessive moisture.
Package Label.Principal Display Panel
Labeling (84876 101 01)
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