Calmoseptine (Anorectal Ointment) Ointment [Calmoseptine Inc. ] -

CALMOSEPTINE (ANORECTAL OINTMENT) OINTMENT [CALMOSEPTINE INC. ]
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NDC	0799-0001-02, 0799-0001-03, 0799-0001-04, 0799-0001-05, 0799-0001-06
Set ID	ff9539ed-d9ae-401d-adbc-df8f1d751431
Category	HUMAN OTC DRUG LABEL
Packager	Calmoseptine Inc.
Generic Name
Product Class
Product Number
Application Number	PART346

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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

INGREDIENTS AND APPEARANCE

CALMOSEPTINE
anorectal ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0799-0001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE RED (UNII: 1K09F3G675)
CHLOROTHYMOL (UNII: LJ25TI0CVT)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
THYMOL (UNII: 3J50XA376E)

#	Item Code	Package Description	Marketing Start Date
Packaging
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