COMFORTE NATURAL MENSTRUAL CRAMP RELIEF CREAM- menthol, methyl salicylate cream

comforte Natural Menstrual Cramp Relief Cream by

Drug Labeling and Warnings

comforte Natural 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]

Active Ingredient Purpose

Active Ingredient Purpose

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

Methyl Salicylate 10% ….….. Topical Analgesic

Purpose

Purpose

Topical Analgesic

Uses

Uses Temporarily relieves minor pain associated with cramps

Warnings

Warnings

For external use only

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

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

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

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

QUESTIONS

Questions? Call 877.590.6257

PRINCIPAL DISPLAY PANEL

NDC: 73603-141-96. 28 g Tube.

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

INGREDIENTS AND APPEARANCE

COMFORTE NATURAL MENSTRUAL CRAMP RELIEF CREAM 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73603-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARAPA PROCERA WHOLE (UNII: I9HWQ4A9EV)
SANDALWOOD OIL (UNII: X7X01WMQ5F)
CALOTROPIS PROCERA WHOLE (UNII: M7MHW69IJ8)
SHEA BUTTER (UNII: K49155WL9Y)
SOYBEAN OIL (UNII: 241ATL177A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73603-141-96	1 in 1 CARTON	05/06/2020
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 not final	part348	05/06/2020

Labeler - PMS4PMS, LLC (117393964)

Establishment
Name	Address	ID/FEI	Business Operations
PMS4PMS, LLC		117393964	manufacture(73603-141)