Otc - Active Ingredient
Lidocaine 4% ...... Purpose: Topical Anesthetic
Pain Relieving Patch
FDA Label NDC 84007-160
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medhome Pharma Inc for the product Pain Relieving (NDC 84007-160). 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, otc - purpose, use in specific populations, warnings, otc - ask doctor/pharmacist, otc - when using, otc - do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Anesthetic
Use In Specific Populations
For temporary relief of pain
Warnings
For external use only
Otc - Ask Doctor/Pharmacist
localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
Conditions worsen
Symptoms persists for more than 7 days
Symptoms clear up and occur again within a few days
Otc - When Using
Use only as directed
Avoid contact with the eyes, mucous membranes or rashed
Do not bandage tightly
Otc - Do Not Use
More than 1 patch at a time
On wounds or damaged skin
With a heating pad
If you are allergic to any ingredients of this product
Otc - Stop Use
localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
Conditions worsen
Symptoms persists for more than 7 days
Symptoms clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use
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.
Indications & Usage
Adult and Children 12 years of age and over:
Clean and dry affected area
Remove film from patch and apply to the skin (see illustration)
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 12 years of age: Consult a doctor
Dosage & Administration
This is a strip, patch dosage form.
The active ingredient strength is 4% w/w.
One patch one time, no more than 8 hours one time.
Inactive Ingredient
Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water
Otc - Questions
E-mail：[email protected]
Other Safety Information
Avoid storing product in direct sunlight
Protect product from excessive moisture
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