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LIDOCAINE PATCH
Lidocaine Patch
FDA Label NDC 81484-501
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Anhui Miao De Tang Pharmaceutical Co., Ltd. for the product Lidocaine Patch (NDC 81484-501). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Lidocaine HCI 4% Purpose:Topical Analgesic
Otc - Purpose
For the temporary relief of pain，LIDOCAINE PATCH
Indications & Usage
LIDOCAINE PATCH to help Temporarily relteves minor pain
Warnings
For external use only. Flammable.
Otc - Do Not Use
More than 1 patch at a time
On wounds or damaged skin
With a heating pad
If you have ever had an allergic reaction to this product or any of its ingredients
Otc - When Using
Use only as directed
Avoid contact with the eyes, mucous membranes or rashes
Do not bandage tightly
Otc - Stop Use
Localized skin reaction occur, such as rash, itching, redness, iritation, pain, swelling and blistering
Condition worsens
Symptoms persist for more than 7 days
Symptoms clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children over 12 years:
·Wash and dry the affected areaRemove backing from patch by firmty grasping both ends and gently pulling until backing separates in the middle
· Carefully remove smaller portion of back,ng from patch and apply exposed portion of patch to aected areaOnce exposed portion of
· patch is pooned.carefully remove remaining backing tocomplelely apply patch to afected areaCarefully remove smaller portion of
· backing from patch and apply exposed portion of patch to affected area
· Use only 1 patch for a maximum of 24 hours
Storage And Handling
· Keep away from direc sunlight or heat
· Store at room temperature (68-77F/20-25°C)
· Protect product from excessive moisture
· Patch comes in individual packaging
Inactive Ingredient
Aluminum Glycinate,Aluminum Hydroxide, Cellulose Gum, Glycerin, Methylparaben, PEG-40 Hydrogenated Castor Oil,Polyacrylic Acid,Polysorbate 80,Propylene Glycol, Ricinus Communis Seed Oil (Castor), Silica, Sodium Polyacrylate,Tartaric Acid,Titanium Dioxide,Urea,Water, Menthol
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