Maxocaine Pain Relieving Roll-on Liquid
FDA Label NDC 72188-170

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prime Commerce, Llc for the product Maxocaine Pain Relieving Roll-on (NDC 72188-170). 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:, keep out of reach of children., do not apply, if pregnant or breast feeding,, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lydocaine HCL 4%

Menthol 1%

Purpose

Topical anesthetic

Use:

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

Warnings:

  • For external use only
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children.

If swallowed, consult physician.

Do Not Apply

  • to wounds or damaged skin.
  • Do not bandage tightly.

If Pregnant Or Breast Feeding,

contact physician prior to use.

Directions:

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.  Chinldren under two-years of age: consult a physician.

Additional Information:

Store at room temperature.

Inactive Information:

Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Cetyl Alcohol, Ethylhexylglycerin, Ilex Paraguayensis (Yerba Mate') Extract, Isopropyl Alcohol, Isopropyl Myristate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Sodium Lauryl Sulfate, Stearic Acid, Triethanolamine

Package Labeling:

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