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  5. Label Information: Calmoseptine

FDA Label for Calmoseptine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS:
    10. CALMOSEPTINE OINTMENT

Calmoseptine Product Label

The following document was submitted to the FDA by the labeler of this product Calmoseptine Inc.. 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.

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.