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LIDOCAINE PATCH
Lidocaine Patch
FDA Label NDC 81484-301
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 81484-301). 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, active ingredient(s), purpose, use, warnings, 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
Active Ingredient(S)
LIDOCAINE 4% Purpose:Topical Analgesic
MENTHOL 1% Purpose: External Analges
Purpose
Topical Anesthetic, External Analges, LIDOCAINE PATCH
Use
LIDOCAINE PATCH to help Temporarily relteves minor pain
Warnings
For external use only. Flammable.
Do Not Use
• More than one patch on your body at a time or on cut, irritated or swollen skin
• On open or puncture wounds
• For more than one week without consulling a doctor.
Otc - When Using
• Use only as directed. Read and邸ow all directions and warnings on this label.
• Rare cases of serious burns have been reported with products of this type.
• Oo not apply to wou心s or damaged, broken or irritated skin
• Do not allow contact with the eyes and mucous membranes.
• Do not bandage tightly or apply local heat (such as heating pads) to the area of use
• Do not use at the same time as other topical analgesics.
• Dispose of used patch in manner that always keeps producl 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.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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.
Directions
Adults and children over 12 years:
• Wash and dry the affected area.
• Remove 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 a什ected area
• Once exposed portion of patch is po奾oned.carefully remove remaining backing tocomplelely apply patch to affected area.
• Carefully 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.
Other Information
- Store at room temperature - do not exceed 86'F, 30'C
Inactive Ingredients
aluminum glycinate, glycerin, sodium polyacrylate. tartaric acid, DMOM hydantoin, water
Package Label - Principal Display Panel
Label (Label)
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