Maxocaine Topical Anesthetic Anorectal

Maxocaine Topical Anesthetic Anorectal
SPL v4
SPL
SPL Set ID 26e8c867-8cb8-4a25-91b1-da45a1edd09a
Route
TOPICAL
Published
Effective Date 2025-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aloe Vera Leaf Water Arnica Montana Whole Indian Frankincense Cannabis Sativa Seed Oil Cetyl Alcohol Dimethicone Ethylhexylglycerin Ilex Paraguariensis Leaf Isopropyl Myristate Dimethyl Sulfone Phenoxyethanol Polysorbate 20 Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-15

Description

Lidocaine 5.0% w/w

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 5.0% w/w

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.
Drug Facts

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.
Package Labeling:

Active Ingredient:

Lidocaine 5.0% w/w

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.

Keep Out of Reach of Children.

If swallowed, consult physician.

Stop Use and Consult Physician

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


Structured Label Content

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.
Drug Facts

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.
Package Labeling:

Active Ingredient:

Lidocaine 5.0% w/w

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.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, consult physician.

Stop Use and Consult Physician (Stop use and consult physician)

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


Advanced Ingredient Data


Raw Label Data

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