Comforte Menstrual Cramp Relief Cream

Manufacturer: PMS4PMS LLC
Effective date: 2024-12-26
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:49:17

Label at a glance#

ProductComforte Menstrual Cramp Relief Cream

Active ingredientMENTHOL

Label structure7 sections

Indications and uses

Temporarily relieves minor pain associated with cramps

Dosage and administration

adults and children over 12 years: apply generously to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 4 times daily ask a doctor children 12 years or younger;

Contacts and useful links#

PhoneLabel contact877.590.6257

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with cramps

Warnings

WARNINGS SECTION

For external use only

if prone to allergic reaction from aspirin or salicylates, consult a doctor before use Allergy alert:

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs.

When using this product

OTC - WHEN USING SECTION

use only as directed
do not bandage tightly or use with a heating pad
avoid contact with eyes or mucuous membranes
do not apply to wounds or damaged skin.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:

apply generously to affected area
massage into painful area until thoroughly absorbed into skin
repeat as necessary, but no more than 4 times daily
ask a doctor children 12 years or younger;

Inactive ingredients

INACTIVE INGREDIENT SECTION

Shea Butter, Carapa Procera Oil, Sunflower Oil, Lavendar Oil, Calotropis Procera Extract, Sandalwood Oil, Red Cabbage Juice, Turmeric, Monoglyceride, Diglyceride

Questions?

OTC - QUESTIONS SECTION

Call 877.590.6257

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageInner Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1148430	menthol 4 % Topical Cream	PSN	3
1148430	menthol 40 MG/ML Topical Cream	SCD	3
1148430	menthol 4 % Topical Cream	SY	3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73603-000-00	Comforte Menstrual Cramp Relief Cream	1 in 1 BOX	CREAM	1		3
73603-000-00	Comforte Menstrual Cramp Relief Cream	28 g in 1 TUBE	CREAM	28		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73603-000	COMFORTE MENSTRUAL CRAMP RELIEF CREAM (MENTHOL) CREAM [PMS4PMS LLC]	3	Current NDC, 2 package rows	20241228_c121537e-3333-4f35-8c77-20086158dff4.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Comforte Menstrual Cramp Relief Cream
MENTHOL
SHEA BUTTER
SUNFLOWER OIL
LAVENDER OIL
SANDALWOOD OIL
TURMERIC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73603-000	73603-000-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SHEA BUTTER	K49155WL9Y	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
LAVENDER OIL	ZBP1YXW0H8	IACT
SANDALWOOD OIL	X7X01WMQ5F	IACT
TURMERIC	856YO1Z64F	IACT
MENTHOL	L7T10EIP3A	ACTIB

Source Document#

Source XML

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
Comforte Menstrual Cramp Relief Cream	MENTHOL	PMS4PMS LLC	c121537e-3333-4f35-8c77-20086158dff4	2024-12-26	Warnings	Exact identifier ndc (package): 73603-000-00 ndc (product): 73603-000 ndc11 (package): 73603000000 spl id: 2a2c1fa4-62e4-e203-e063-6294a90a6fd5 spl set id: c121537e-3333-4f35-8c77-20086158dff4

Reported adverse events (FAERS/openFDA)#

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