FLEXACURE- menthol spray 
Symedic LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Menthol USP 2.25%

Apply as needed.

(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.

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

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)

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

Dist. by: Symedic LLC Las Vegas, NV 89147

MADE IN USA ©2019 FlexaCure

www.flexacure.com

Uses: Temporarily relieves minor pain associated with:

• arthritis • simple backache • muscle strains

• sprains • bruises • cramps

Topical Analgesic

Active Ingredients

FLEXACURE 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71402-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71402-007-0129 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/14/2019
Labeler - Symedic LLC (060844542)

Revised: 10/2019
Document Id: 94e7337b-c590-bf64-e053-2a95a90a1dbf
Set id: 94e7337b-c58f-bf64-e053-2a95a90a1dbf
Version: 4
Effective Time: 20191014
 
Symedic LLC