FLEXACURE- menthol spray

FlexaCure by

Drug Labeling and Warnings

FlexaCure by is a Otc medication manufactured, distributed, or labeled by Symedic LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol USP 2.25%

DOSAGE & ADMINISTRATION

Apply as needed.

WARNINGS

(for external use only)

When using this product

use only as directed

do not bandage tightly or use with heating pad

avoid contact with eyes or mucous membranes

do not apply to wounds or damaged skin

Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present irritation develops

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INSTRUCTIONS FOR USE

adults and children 12 years of age and older:

apply generously to affected area massage into painful area until thoroughly absorbed into skin repeat if necessary, but not more than 3 to 4 times daily

children under 12 years of age: ask a doctor

INACTIVE INGREDIENT

Arnica Montana Flower Extract, Chondroitin Sulfate, Dimethyl Sulfone USP (MSM), Dimethyl Sulfoxide USP (DMSO), Glucosamine HCL (Shellfish), Glycerin, Hydrogen Peroxide, Magnesium Chloride, Propylene Glycol, Water (Aqua)

OTHER SAFETY INFORMATION

Persons with a known allergy to shellfish or sulfur should not use this product

STATEMENT OF IDENTITY

Dist. by: Symedic LLC Las Vegas, NV 89147

MADE IN USA ©2019 FlexaCure

www.flexacure.com

INDICATIONS & USAGE

Uses: Temporarily relieves minor pain associated with:

arthritis simple backache muscle strains

sprains bruises cramps

PURPOSE

Topical Analgesic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLEXACURE 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71402-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
DIMETHYL SULFATE (UNII: JW5CW40Z50)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71402-007-01	29 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/14/2019

Labeler - Symedic LLC (060844542)