Calmoseptine Ointment
FDA Label NDC 0799-0001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Calmoseptine Inc. for the product Calmoseptine (NDC 0799-0001). 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 ingredients, purpose, uses, warnings, when using this product, stop use and ask doctor if, 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

Active Ingredients

Lanolin 15.7%  

Menthol 0.44%

Petrolatum 24%

Zinc Oxide 20.6%

Purpose

Active Ingredients                                        Purpose
Lanolin 15.7%...........................Anorectal Protectant
Menthol 0.44%...........................Anorectal Analgesic
Petrolatum 24%........................Anorectal Protectant
Zinc Oxide 20.6%......Anorectal Protectant, Astringent 

Uses

  • Temporarily protects irritated areas.
  • For the temporary relief of:
  •   local itching and discomfort in the perianal area
  •   pain or burning
  •   skin irritations

Warnings

For external use only

When Using This Product

* Certain persons can develop allergic reactions to ingredients in this product.
* Do not put this product into the rectum by using fingers or any mechanical device or applicator.
* Do not exceed the recommended daily dosage unless directed by a doctor.
* Avoid contact with eyes.

Stop Use And Ask Doctor If

  • condition worsens or does not improve within 7 days
  • bleeding occurs
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

Keep Out Of Reach Of Children.

In case of accidental ingestion contact a physician or Poison Control Center immediately.

Directions

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
Gently dry by patting or blotting with toilet tissue or a soft cloth or air dry before application of this product.
Apply externally to the affected area up to 6 times daily or after each bowel movement.
Children under 12 years of age: consult a doctor.

Inactive Ingredients:

calamine, chlorothymol, glycerin, phenol,

sodium bicarbonate, and thymol in a suitable ointment base

* Please review the disclaimer below.