Hemorrhoid Anesthetic Ointment
FDA Label NDC 83650-110

10 label sections · Submitted to the FDA by Savvy Care And Cosmetics · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Savvy Care And Cosmetics for the product Hemorrhoid Anesthetic (NDC 83650-110). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCL 0.25%

Otc - Purpose

Purpose

Protectant

Protectant

Vasoconstrictor

Indications & Usage

Uses

  • For the temporary relief of local anorectal burning and discomfort associated with hemmorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles.

Warnings

Warnings

For external use only

Otc - Stop Use

  • Stop use and ask a doctorif condition worsens, or if symptoms persist for more than 7 days or clean-up and occur again within a few days.

  • Do not exceed the recommended daily dosage unless directed by a doctor.

  • In case of bleeding, consult a doctor promptly.

  • Certain persons can develop allergic reactions to ingredients in this product.

  • If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

  • If you are pregnant, do not use this product without first consulting a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If ingested seek medical attention immediately or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • Cleanse the affected area with mild soap and warm water, rinse thoroughly.
  • Dry by patting or blotting with toilet tissue or soft cloth before applying this product.
  • Cover the entire affected area with a thin layer 1 to 3 times daily.
  • Children under 12 years of age need to consult a doctor before using this product.

Other

Other Information

  • Store at room temperature 20°C to 25°C (68°F to 77°F)
  • Lot No. & Exp. Date: see crimp of tube.

Inactive Ingredient

Inactive Ingredients

Purified water, benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, mineral oil, paraffin, propylparaben, shark liver oil, thyme oil, tocopherol acetate, yellow wax.

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