CALMOSEPTINE- anorectal ointment ointment 
Calmoseptine Inc.

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Calmoseptine Ointment

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

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

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

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 DrugM01508/01/1950
Labeler - Calmoseptine Inc. (783409394)
Establishment
NameAddressID/FEIBusiness Operations
Calmo Manufacturing Inc.015850149manufacture(0799-0001) , pack(0799-0001) , label(0799-0001)

Revised: 1/2025
Document Id: 2ba19ed3-445d-e95a-e063-6394a90abb3f
Set id: ff9539ed-d9ae-401d-adbc-df8f1d751431
Version: 14
Effective Time: 20250113
 
Calmoseptine Inc.