COMFORTE MENSTRUAL CRAMP RELIEF CREAM- menthol cream

Comforte Menstrual Cramp Relief Cream by

Drug Labeling and Warnings

Comforte Menstrual Cramp Relief Cream by is a Otc medication manufactured, distributed, or labeled by PMS4PMS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Menthol 4%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with cramps

Warnings

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

• 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

• 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,

ask a health professional before use.

Keep out of reach of children.

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

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 
• ask a doctor children 12 years or younger;

Inactive ingredients

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

Questions?

Call 877.590.6257

Package Labeling:

INGREDIENTS AND APPEARANCE

COMFORTE MENSTRUAL CRAMP RELIEF CREAM 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73603-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SANDALWOOD OIL (UNII: X7X01WMQ5F)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73603-000-00	1 in 1 BOX	02/01/2023	10/30/2028
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/01/2023	10/30/2028

Labeler - PMS4PMS LLC (117393964)