FDA.reportPublic FDA data

comforte Natural Menstrual Cramp Relief Cream

Manufacturer
PMS4PMS, LLC
Effective date
2020-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:32:31

Label at a glance#

Productcomforte Natural Menstrual Cramp Relief Cream
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure8 sections

Indications and uses

Uses Temporarily relieves minor pain associated with cramps

Dosage and administration

Directions 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 * children 12 years or younger; ask a doctor

Label contents#

Full prescribing information#

Active Ingredient Purpose

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Menthol 1.4%......................... Topical Analgesic

Methyl Salicylate 10% ….….. Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Uses Temporarily relieves minor pain associated with cramps

Warnings

WARNINGS SECTION

Warnings

For external use only

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

OTC - STOP USE SECTION

Stop use and ask a doctor if * condition worsens or symptoms persist for more than 7 days * symptoms clear up and occur again within a few days * excessive skin irritation occurs

OTC - WHEN USING SECTION

When using this product * 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

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 * children 12 years or younger; ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients Calotropis Procera Extract, Carapa Procera Oil, Sandalwood Oil, Shea Butter, Soybean Oil

OTC - QUESTIONS SECTION

Questions? Call 877.590.6257

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 73603-141-96. 28 g Tube.

comforte tube label imagecomforte tube label image

NDC 73603-141-96. Outer carton for 28 g Tube..

Outer carton imageOuter carton image

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73603-14173603-141-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARAPA PROCERA WHOLEI9HWQ4A9EVIACT
SANDALWOOD OILX7X01WMQ5FIACT
CALOTROPIS PROCERA WHOLEM7MHW69IJ8IACT
SHEA BUTTERK49155WL9YIACT
SOYBEAN OIL241ATL177AIACT
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML · Source PDF

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dd305be0-1e77-7b69-e053-2a95a90ab887a4fe2ac4-08f2-86e1-e053-2995a90aac302022-04-21WarningsExact identifier
spl set id: a4fe2ac4-08f2-86e1-e053-2995a90aac30

Reported adverse events (FAERS/openFDA)#

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