Maxocaine Topical Anesthetic Anorectal Cream
FDA Label NDC 72188-076

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 Topical Anesthetic Anorectal (NDC 72188-076). 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 drug facts, active ingredient:, purpose, use(s):, warnings:, stop use and consult physician, keep out of reach of children., directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient:

Lidocaine 5.0% w/w

Purpose

Topical Anesthetic

Use(S):

For the temporary relief of pain and discomfort associated with anorectal disorders.

Warnings:

  • For external use only
  • Avoid contact with eyes.
  • Do not exceed recommended daily dosage unless directed by physician.

Stop Use And Consult Physician

if rectal bleeding occurs, if allergic reaction develops, if condition worsens or does not improve within seven days.

Keep Out Of Reach Of Children.

If swallowed, consult physician.

Directions:

When practical, cleanse the affected area with mild soap and warm water, then rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.

  • Adults and children 12-years and over: apply externally to the affected area up to five times per day.
  • Children under 12-years: Consult a physician.

Other Ingredients:

Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionzied Water), Arnica Montana Extract, Boswellia Serrata Extract, Cannabis Sativa (Hemp) Seed Oil, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Ilex Paraguariensis (Yerba Mate) Extract, Isopropyl Myristate, methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Stearic Acid, Triethanolamine.

Package Labeling:

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