Calmoseptine Ointment

Manufacturer: Calmoseptine Inc. | Calmo Manufacturing Inc.
Effective date: 2025-01-13
Label type: HUMAN OTC DRUG LABEL
Version: 14
Source: full-release
Hydrated at: 2026-06-01 00:52:44

Label at a glance#

ProductCalmoseptine

Active ingredientLANOLIN, MENTHOL, PETROLATUM, ZINC OXIDE

Label structure8 sections

Indications and uses

Temporarily protects irritated areas. For the temporary relief of: local itching and discomfort in the perianal area pain or burning skin irritations

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lanolin 15.7%

Menthol 0.44%

Petrolatum 24%

Zinc Oxide 20.6%

Purpose

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

Temporarily protects irritated areas.
For the temporary relief of:
local itching and discomfort in the perianal area
pain or burning
skin irritations

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

* 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

OTC - ASK DOCTOR SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion contact a physician or Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

calamine, chlorothymol, glycerin, phenol,

sodium bicarbonate, and thymol in a suitable ointment base

Calmoseptine Ointment

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calmoseptine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1946481	Calmoseptine 15.7 % / 0.44 % / 24 % / 20.6 % Topical Ointment	PSN	14
1946476	lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical Ointment	PSN	14
1946481	lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calmoseptine]	SBD	14
1946476	lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment	SCD	14
1946481	Calmoseptine Ointment (lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG) Topical Ointment	SY	14
1946481	Calmoseptine OIntment (lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % ) Topical Ointment	SY	14
1946476	Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment	SY	14
1946481	Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment [Calmoseptine]	SY	14
1946476	lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical Ointment	SY	14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0799-0001-02	Calmoseptine	71 g in 1 TUBE	OINTMENT	71	14
0799-0001-03	Calmoseptine	71 g in 1 JAR	OINTMENT	71	14
0799-0001-04	Calmoseptine	113 g in 1 TUBE	OINTMENT	113	14
0799-0001-05	Calmoseptine	3.5 g in 1 PACKET	OINTMENT	3.5	14
0799-0001-06	Calmoseptine	20 g in 1 TUBE	OINTMENT	20	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0799-0001	CALMOSEPTINE (ANORECTAL OINTMENT) OINTMENT [CALMOSEPTINE INC.]	14	Current NDC, Legacy NDC, 5 package rows	20250116_ff9539ed-d9ae-401d-adbc-df8f1d751431.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0799-0001-02	GM - Gram	0799-0001	95b8e2fc-087a-4e01-83db-ce0dba8b6a81	1	2012-07-24
0799-0001-03	GM - Gram	0799-0001	6b232653-4859-4f99-b068-04502e33711f	1	2017-10-13
0799-0001-04	GM - Gram	0799-0001	e98285a3-d153-478e-9313-f028945ee9c3	1	2012-07-24
0799-0001-05	GM - Gram	0799-0001	0529cae0-8e6d-4662-b39b-f4c593dd85b8	1	2014-11-05
0799-0001-06	GM - Gram	0799-0001	86923745-4ac0-44a9-8331-e4693c473206	1	2023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	8
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	8
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	8
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	8
Chlorothymol	INACTIVE INGREDIENT	LJ25TI0CVT	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	8
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	8
Lanolin	INACTIVE INGREDIENT	7EV65EAW6H	8
Phenol	INACTIVE INGREDIENT	339NCG44TV	8
Sodium Bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	8
Thymol	INACTIVE INGREDIENT	3J50XA376E	8

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Calmoseptine
anorectal ointment
FERRIC OXIDE RED
CHLOROTHYMOL
GLYCERIN
PHENOL
SODIUM BICARBONATE
THYMOL
LANOLIN
MENTHOL
PETROLATUM
ZINC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0799-0001	0799-0001-02, 0799-0001-03, 0799-0001-04, 0799-0001-05, 0799-0001-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FERRIC OXIDE RED	1K09F3G675	IACT
CHLOROTHYMOL	LJ25TI0CVT	IACT
GLYCERIN	PDC6A3C0OX	IACT
PHENOL	339NCG44TV	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
THYMOL	3J50XA376E	IACT
LANOLIN	7EV65EAW6H	ACTIB
MENTHOL	L7T10EIP3A	ACTIB
PETROLATUM	4T6H12BN9U	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 354 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Phenol	PHENOL	339NCG44TV	INJECTION, SUSPENSION / SUBCUTANEOUS	0.07 %w/v		Exact identifier — unii candidate 114 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAVENOUS	812 mg		Exact identifier — unii candidate 204 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	CAPSULE, DELAYED RELEASE PELLETS / ORAL		4 mg	Exact identifier — unii candidate 204 equally ranked IID candidates
Thymol	THYMOL	3J50XA376E	LIQUID / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii candidate 204 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION, SOLUTION / INTRAMUSCULAR		75 mg	Exact identifier — unii candidate 114 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	TABLET, FILM COATED / ORAL		86 mg	Exact identifier — unii candidate 204 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION / SUBCUTANEOUS		48 mg	Exact identifier — unii candidate 114 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION / INTRASYNOVIAL	0.5 %w/v		Exact identifier — unii candidate 114 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	DOUCHE / VAGINAL	0.14 %w/w		Exact identifier — unii candidate 114 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, SOLUTION / INTRAVENOUS		52 mg	Exact identifier — unii candidate 204 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	LIQUID / SUBCUTANEOUS	0.5 %w/v		Exact identifier — unii candidate 114 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	TABLET, FILM COATED / ORAL		86 mg	Exact identifier — unii candidate 204 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION / INTRAMUSCULAR		48 mg	Exact identifier — unii candidate 114 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION / INTRASYNOVIAL	0.5 %w/v		Exact identifier — unii candidate 114 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	TABLET / ORAL	1300 mg		Exact identifier — unii candidate 204 equally ranked IID candidates
Thymol	THYMOL	3J50XA376E	LIQUID / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRATHECAL	0.05 mg		Exact identifier — unii candidate 204 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION / INTRALESIONAL	0.5 %w/v		Exact identifier — unii candidate 114 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 204 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION, SOLUTION / INTRAVENOUS		75 mg	Exact identifier — unii candidate 114 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION / INTRA-ARTICULAR	0.5 %w/v		Exact identifier — unii candidate 114 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION / INTRAMUSCULAR		48 mg	Exact identifier — unii candidate 114 equally ranked IID candidates
Thymol	THYMOL	3J50XA376E	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 12 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		3219 mg	Exact identifier — unii candidate 204 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 204 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 204 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 6 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, SOLUTION / INTRAVENOUS		52 mg	Exact identifier — unii candidate 204 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	TABLET, COATED / ORAL	10.6 mg		Exact identifier — unii candidate 204 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION, SOLUTION / INTRAVENOUS		75 mg	Exact identifier — unii candidate 114 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	LIQUID / SUBCUTANEOUS	0.5 %w/v		Exact identifier — unii candidate 114 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	TABLET, CHEWABLE / ORAL	140 mg		Exact identifier — unii candidate 204 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1000 mg		Exact identifier — unii candidate 204 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	TABLET, ORALLY DISINTEGRATING / ORAL		107 mg	Exact identifier — unii candidate 204 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION / INTRAVENOUS		48 mg	Exact identifier — unii candidate 114 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1000 mg		Exact identifier — unii candidate 204 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION / SUBCUTANEOUS		48 mg	Exact identifier — unii candidate 114 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	SOLUTION / ORAL	ADJ PH		Exact identifier — unii candidate 204 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAMUSCULAR		175 mg	Exact identifier — unii candidate 204 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION / INTRAMUSCULAR		48 mg	Exact identifier — unii candidate 114 equally ranked IID candidates
Thymol	THYMOL	3J50XA376E	LIQUID / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
Thymol	THYMOL	3J50XA376E	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 12 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS		160 mg	Exact identifier — unii candidate 204 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 204 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	2 mg		Exact identifier — unii candidate 114 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRATHECAL	0.05 mg		Exact identifier — unii candidate 204 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION / SUBCUTANEOUS		48 mg	Exact identifier — unii candidate 114 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	DOUCHE / VAGINAL	0.14 %w/w		Exact identifier — unii candidate 114 equally ranked IID candidates
Thymol	THYMOL	3J50XA376E	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 12 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1000 mg		Exact identifier — unii candidate 204 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION, SOLUTION / SUBCUTANEOUS	0.55 %w/v		Exact identifier — unii candidate 114 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION / INTRA-ARTICULAR	0.5 %w/v		Exact identifier — unii candidate 114 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAVITREAL	0.18 %w/v		Exact identifier — unii candidate 204 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 204 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION / INTRAVENOUS		48 mg	Exact identifier — unii candidate 114 equally ranked IID candidates
Phenol	PHENOL	339NCG44TV	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	2 mg		Exact identifier — unii candidate 114 equally ranked IID candidates
Sodium Bicarbonate	SODIUM BICARBONATE	8MDF5V39QO	LOZENGE / ORAL		100 mg	Exact identifier — unii candidate 204 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calmoseptine	ANORECTAL OINTMENT	Calmoseptine Inc.	ff9539ed-d9ae-401d-adbc-df8f1d751431	2025-01-13	Warnings	Exact identifier ndc (package): 0799-0001-04 ndc (package): 0799-0001-05 ndc (package): 0799-0001-03 ndc (package): 0799-0001-02 ndc (package): 0799-0001-06 ndc (product): 0799-0001 ndc11 (package): 00799000104 ndc11 (package): 00799000106 ndc11 (package): 00799000103 ndc11 (package): 00799000102 ndc11 (package): 00799000105 spl id: 2ba19ed3-445d-e95a-e063-6394a90abb3f spl set id: ff9539ed-d9ae-401d-adbc-df8f1d751431

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.