Active Ingredient
Lidocaine 4% ...... Purpose: Topical Anesthetic
Lidocaine Pain Relief Gel -patch
FDA Label NDC 83602-231
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. for the product Lidocaine Pain Relief Gel -patch (NDC 83602-231). 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, uses, warnings, do not use, when using this product, ask a doctor if:, stop use if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Uses
Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.
Warnings
For external use only
Do Not Use
· more than 1 patch on your body at a time or with other topical anesthetics at the same time
· on wounds or damaged skin
· with a heating pad or device
· with other ointments, creams, sprays, or liniments
· if you are allergic to any ingredients of this product
When Using This Product
· use only as directed
· avoid contact with the eyes, mucous membranes, or rashes
· do not bandage tightly
· dispose of used patch in manner that always keeps product 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.
Ask A Doctor If:
· localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
· condition worsens
· symptoms persist for more than 7 days
· symptoms clear up and occur again within a few days
Stop Use If:
· localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
· condition worsens
· symptoms persist for more than 7 days
· symptoms clear up and occur again within a few days
Pregnancy Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed accidentally , get medical help or contact with Poison Control Center immediately.
Directions
Adults and Children above 12 years old:
· Clean and dry the affected area.
· Tear off the protective film and apply the exposed part of the patch to the affected area.
· Carefully remove remaining film while pressing the patch firmly on the skin.
· Apply 1 patch at a time to affected area, not more than 3 to 4 times daily.
· Remove patch from the skin after at most 8-hour application
Children under age of 12:Consult a doctor
Other Information
Store at 20°C to 25°C (68°F - 77°F)
Store in a cool dry place away from direct sunlight
Inactive Ingredients
Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polysorbate 80, PropyleneGlycol, Polyacrylic Acid, Povidone, Propylparaben, Sodium Polyacrylate, Titanium Dioxide, Tartaric Acid, Water
Questions Or Comments?
Package Label. Principal Display Panel
Patch (Patch)
13 Patches (13 Patch)
10 Patches (10 Patch)
16 Patches (16 Patch)
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