Active Ingredient
Lidocaine 4%
Mybiooid Lidocaine 4% Pain Relieving Gel-patch
FDA Label NDC 88068-001
13 label sections · Submitted to the FDA by Avelon Trading Limited · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avelon Trading Limited for the product Mybiooid Lidocaine 4% Pain Relieving Gel-patch (NDC 88068-001). 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 ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Use
For the temporary relief of pain
Warnings
For external use only.
Do Not Use
• more than one patch at a time
• on wounds or damaged skin
• with a heating pad
• if allergic to any ingredients of this product
When Using
When using this product:
• use only as directed
• avoid contact with eyes and mucous membranes
• do not bandage tightly
Stop Use
Stop use and ask a doctor if:
• skin reactions occur, such as redness, irritation, pain, swelling, or blistering
• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
Ask Doctor
If pregnant or breast-feeding, ask a health professional before use.
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 12 years of age and over:
• clean and dry affected area
• remove patch and apply patch to affected area (see illustration)
• apply one patch at a time, not more than 3 to 4 times daily
• remove patch after no more than 8 hours
Children under 12 years: consult a doctor
Other Information
• store away from direct sunlight
• protect from excessive moisture
Inactive Ingredients
Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Propyparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
Principal Display Panel
1 (15patch)
2 (33patch)
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