CALMOSEPTINE- anorectal ointment ointment

Calmoseptine by

Drug Labeling and Warnings

Calmoseptine by is a Otc medication manufactured, distributed, or labeled by Calmoseptine Inc. , Calmo Manufacturing Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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)