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DRUG FACTS
Call 1-800-PEDIFIX (733-4349),
write to PediFix, 301 Fields Lane,
Brewster, NY 10509, or
visit pedifix.com.
Pedifix Lidocaine Pain-relief Patches Patch
FDA Label NDC 68927-3700
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pedifix, Inc for the product Pedifix Lidocaine Pain-relief Patches (NDC 68927-3700). 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 4%
Otc - Purpose
Topical Anesthetic
Indications & Usage
Temporarily relieves minor pain
Warnings
For external use only
Otc - Do Not Use
• On cut, irritated, or swollen skin. • On puncture wounds. • For more than one week without
consulting a doctor. • If you are allergic to any active or inactive ingredient. • If the pouch is
damaged or opened.
Otc - When Using
- Use only as directed.
- Read and follow all directions and warnings on this carton.
- Avoid contact with the eyes, mucous membranes, or rashes.
- Do not use at the same time as other topical analgesics.
- Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
- Do not microwave.
- Dispose of used patches in a manner that always keeps the product away from children and pets. Used patches still contain the drug and could produce serious adverse effects if a child or pet chews or ingests them.
Otc - Stop Use
- Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, or blistering.
- Conditions worsen.
- Symptoms persist for more than 7 days or clear up and occur again within a few days.
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
(1-800-222-1222) immediately.
Dosage & Administration
Adults and children 12 years of age and over:
- Clean and dry the affected area.
- Carefully remove the backing from the patch starting at the corner.
- Apply the sticky side of the patch to the affected area.
- Use one patch for up to 8 hours.
- Discard the patch after a single use.
Children under 12 years of age: Consult a physician before use.
Other Safety Information
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
Inactive Ingredient
Acrylic block co-polymer adhesive
Package Label.Principal Display Panel
PediFix
Meidcal Footcare
Lidocain
Pain-Relief
Patches
Relieve Pain Instantly!
Scissor-Trim to Any Size
Water-Resistant
Unscented
4% Lidocaine Topical Anesthetic
Maximum Strength
6
Medicated Patches
Trim to Any Size
Pedifixlidocainepatches (Pedifixlidocainpatches)
* Please review the disclaimer below.
