Otc - Active Ingredient
Lidocaine 4%
Lidocaine 4% Gel Patch
FDA Label NDC 71318-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dr. Sabharwal's Wound Care for the product Lidocaine 4% Gel Patch (NDC 71318-112). 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, indications & usage, otc - purpose, warnings, otc - do not use, otc - when using, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Temporarily Relieves Minor Pain
Otc - Purpose
Topical Anesthetic
Warnings
For external use only
Otc - Do Not Use
- More than one patch on your body at a time
- On cut, irritated swollen skin
- On puncture wounds
- For more than one week without consulting a doctor
- At the same time as other topical analgesics
Otc - When Using
Use only as directed.
Read and follow all directions and warnings on this label.
Rare case of serious burns have been reported with products of this type.
Do not apply to wounds 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 analgesic.
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
A transient burning sensation may occur uopn application but generally disappears in several days.
If a severe burning sensation occurs, discontinue use immediately.
Discontinue use at least 1 hour before a bath or shower.
Do not use immediately after a bath or shower.
Stop Use And Ask A Doctor If
Condition worsens
Redness is present.
Irritation develops.
Symptoms persist for more than 7 days or clear up and occur again within a few days.
You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.
Otc - Pregnancy Or Breast Feeding
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Instructions For Use
Adult and children over 12 years
Clean and dry affected area.
Remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle.
Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area.
Use 1 patch for up to 12 hours.
Children 12 years or younger:
ask a doctor
Storage And Handling
Store at room temperature 20-25 0C (68-77 0F)
Inactive Ingredient
Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Borax, Carbomer, Collodial Silicon
Dioxide, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide.
Otc - Questions
Questions? Call 718-739-5680
Dosage & Administration
Topical Patch for External Use Only
Package Label.Principal Display Panel
Lidocaine Patch (Lidocaine Patch Artworkd)
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