FDA Label for Maxocaine Topical Anesthetic Anorectal

View Indications, Usage & Precautions

Maxocaine Topical Anesthetic Anorectal Product Label

The following document was submitted to the FDA by the labeler of this product Prime Commerce, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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