FLEXIN- menthol and capsaicin patch 
Whyteman Labs 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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DRUG FACTS :

Menthol 5.00%

External Analgesic/Counterirritant

Capsaicin 0.0375%

External Analgesic

USES :

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness.

WARNINGS :

  • Keep out of reach of children. Consult physician for use in children under 12.

  • Do not use if you are allergic to Menthol or Capsaicin.

  • Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occurs again within a few days, or if rash, itching or excessive skin irritation occurs.

DIRECTIONS :

INACTIVE INGREDIENTS :

Water, Glycerine, Sodium Polyacrylate, Polysorbate 80,

Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt,

Diazolidinyl Urea, Methylparaben, Iodopropynyl Butylcarbamate, Propylparaben.

Store below 25°C (77°F)

Avoid direct sunlight.

PRINCIPAL DISPLAY PANEL

Flexin Label

FLEXIN 
menthol and capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69695-1974
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.000375 
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETIC ACID (UNII: 9G34HU7RV0)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69695-1974-115 in 1 BOX
15 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/13/2015
Labeler - Whyteman Labs LLC (079758831)

Revised: 11/2015
Document Id: 2448c701-124c-0634-e054-00144ff88e88
Set id: 1ac3e745-9fbe-0f7d-e054-00144ff8d46c
Version: 2
Effective Time: 20151111
 
Whyteman Labs LLC