Active Ingredients
Lidocaine 4%
Lidocaine Pain Relief Gel Patch
FDA Label NDC 67777-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex for the product Lidocaine Pain Relief Gel Patch (NDC 67777-009). 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 ingredients, puropose, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Puropose
Topical anesthetic
Use
For temporary relief of pain
Warnings
For external use only
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
When Using This Product
- use only as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
Stop Use And Ask A Doctor If
- localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop
- conditions worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
If Pregnant Or Breast Feeding
ask a health professional before use
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and over:
- clean and dry affected area
- remove film from patch and apply to the skin
- apply 1 patch at a time to affected area, not more than 3 to 4 times daily
- patch should not be applied longer than an 8 hour period
Children under 12 years of age: consult a doctor
Other Information
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
Inactive Ingredients
Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Tween 80, Water
Questions?
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