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Calmoseptine (Calmoseptine Inc.)

Available Formats

Dosage Form Package Information Links
OINTMENT 3.5 g in 1 PACKET (0799-0001-05) Label Information
OINTMENT 71 g in 1 TUBE (0799-0001-02) Label Information
OINTMENT 113 g in 1 TUBE (0799-0001-04) Label Information

Complete Calmoseptine Information

  • 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


  • Calmoseptine Ointment

    Calmoseptine Ointment


  • INGREDIENTS AND APPEARANCE
    CALMOSEPTINE 
    anorectal ointment ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0799-0001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN 15.7 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.44 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 24 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20.6 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CHLOROTHYMOL (UNII: LJ25TI0CVT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0799-0001-02 71 g in 1 TUBE; Type 0: Not a Combination Product 01/04/1999
    2 NDC:0799-0001-03 71 g in 1 JAR; Type 0: Not a Combination Product 08/01/1950
    3 NDC:0799-0001-04 113 g in 1 TUBE; Type 0: Not a Combination Product 08/01/1988
    4 NDC:0799-0001-05 3.5 g in 1 PACKET; Type 0: Not a Combination Product 06/01/2001
    5 NDC:0799-0001-06 20 g in 1 TUBE; Type 0: Not a Combination Product 07/03/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 08/01/1950
    Labeler - Calmoseptine Inc. (783409394)
    Establishment
    Name Address ID/FEI Business Operations
    Calmo Manufacturing Inc. 015850149 manufacture(0799-0001) , pack(0799-0001) , label(0799-0001)