Benepatch
FDA Label NDC 69418-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meds Direct Rx, Inc. for the product Benepatch (NDC 69418-002). 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 active ingredients:, uses:, warnings:, keep out of reach of children., directions:, other ingredients:, package labeling for benepatch, 15 count (69418-002-01), 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%

Uses:

For temporary relieft of pain associated with minor cuts, scrapes and minor skin irritations.

Warnings:

  • For external use only.
  • Avoid contact with eyes.
  • Do not apply on open wounds or damaged skin.
  • If symptoms persist for more than seven days, discontinue use and consult physician.
  • 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.

Keep Out Of Reach Of Children.

If swallowed, consult physician.

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 5 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.

Package Labeling For Benepatch, 15 Count (69418-002-01)

Front (Front)

Front (Front)

Back (Back)

Back (Back)

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