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NDC 00799-0001-06 Calmoseptine 15.7; .44; 24; 20.6 g/100g; g/100g; g/100g; g/100g Details

Calmoseptine 15.7; .44; 24; 20.6 g/100g; g/100g; g/100g; g/100g

Calmoseptine is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Calmoseptine Inc.. The primary component is LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE.

Product Information

NDC	00799-0001
Product ID	0799-0001_58f828af-7e71-4d87-b0d3-6e4174fb6293
Associated GPIs	90979902454219
GCN Sequence Number	065841
GCN Sequence Number Description	menthol/zinc oxide OINT. (G) 0.44-20.6% TOPICAL
HIC3	L3A
HIC3 Description	PROTECTIVES
GCN	27937
HICL Sequence Number	002350
HICL Sequence Number Description	MENTHOL/ZINC OXIDE
Brand/Generic	Brand
Proprietary Name	Calmoseptine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Anorectal Ointment
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	15.7; .44; 24; 20.6
Active Ingredient Units	g/100g; g/100g; g/100g; g/100g
Substance Name	LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE
Labeler Name	Calmoseptine Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00799-0001-06 (00799000106)

Pricing Information	N/A
NDC Package Code	0799-0001-06
Billing NDC	00799000106
Package	20 g in 1 TUBE (0799-0001-06)
Marketing Start Date	2017-07-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ff9539ed-d9ae-401d-adbc-df8f1d751431 Details

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	08/01/1950

Labeler - Calmoseptine Inc. (783409394)

Name	Address	ID/FEI	Business Operations
Establishment
Calmo Manufacturing Inc.		015850149	manufacture(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