Label: CALMOSEPTINE- anorectal ointment ointment

  • NDC Code(s): 0799-0001-02, 0799-0001-03, 0799-0001-04, 0799-0001-05, view more
    0799-0001-06
  • Packager: Calmoseptine Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 22, 2019

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  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0799-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN15.7 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.44 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM24 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CHLOROTHYMOL (UNII: LJ25TI0CVT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0799-0001-0271 g in 1 TUBE; Type 0: Not a Combination Product01/04/1999
    2NDC:0799-0001-0371 g in 1 JAR; Type 0: Not a Combination Product08/01/1950
    3NDC:0799-0001-04113 g in 1 TUBE; Type 0: Not a Combination Product08/01/1988
    4NDC:0799-0001-053.5 g in 1 PACKET; Type 0: Not a Combination Product06/01/2001
    5NDC:0799-0001-0620 g in 1 TUBE; Type 0: Not a Combination Product07/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34608/01/1950
    Labeler - Calmoseptine Inc. (783409394)
    Establishment
    NameAddressID/FEIBusiness Operations
    Calmo Manufacturing Inc.015850149manufacture(0799-0001) , pack(0799-0001) , label(0799-0001)
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