CALMOSEPTINE- anorectal ointment ointment 
Calmoseptine Inc.

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.

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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 Ointment

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)

Revised: 1/2019
Document Id: 58f828af-7e71-4d87-b0d3-6e4174fb6293
Set id: ff9539ed-d9ae-401d-adbc-df8f1d751431
Version: 11
Effective Time: 20190122
 
Calmoseptine Inc.