Lidonexe
FDA Label NDC 69329-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Patchwerx Labs, Inc. for the product Lidonexe (NDC 69329-002). 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 lidonexe patch, active ingredients:, purpose, uses:, warnings, keep out of reach of children., other, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients:
Lidocaine HCL 4.00%
Menthol 1.00%
Purpose
Topical Analgesic
External Analgesic
Uses:
For temporary relief of pain associated with minor cuts, scrapes and minor skin irritations.
Warnings
- For external use only
- Avoid contact with eyes
- Do not apply to open wounds or damaged skin.
- If symptoms persist for more than seven days, discontinue use and consult physician.
Keep Out Of Reach Of Children.
If swallowed, consult physician.
Other
- Do not bandage tightly
- If pregnant or breast feeding, contact physician prior to use.
- Do not use in large quantities, particularly over raw surfaces or blistered areas.
Directions
- Clean and dry affected area.
- Remove patch from backing and apply to affected area.
- Use only one patch at a time, and maximum of four patches/day.
- Leave patch on affected area for up to 8-hours.
- Do not use patches for longer than five consecutive days.
- Children under 12 should consult physician prior to use.
Other Ingredients:
Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-80, Sodium Lauryl Sulfate, Triethanolamine, FD C Blue 1, FD C Yellow 5.
Store Below 25 Degrees. Avoid Direct Sunlight.
Lidonexe 25 Patches (69329 -002-25)
Lindonexe_label_small.jpg (Lindonexe Label Small)
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