FLEXIN- menthol and capsaicin patch

Flexin by

Drug Labeling and Warnings

Flexin by is a Otc medication manufactured, distributed, or labeled by Whyteman Labs LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS :

ACTIVE INGREDIENT

Menthol 5.00%

PURPOSE

External Analgesic/Counterirritant

ACTIVE INGREDIENT

Capsaicin 0.0375%

PURPOSE

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 :

• For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
• Do not cover with bandage.
• Do not use on wounds or damaged skin.

• 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 :

• Adults and children 12 years and over apply to affected area; change patch 2 to 3 times daily.
• Children under 12 years, consult a physician before use.
• How to apply:
• Clean and dry affected area.
• Cut open pouch and remove patch. Remove protective film and apply directly to area of pain.
• Apply to affected area not more than 3 times daily.
• Wash hands with soap after applying patch.
• Reseal pouch containing unused patches.

INACTIVE INGREDIENTS :

Water, Glycerine, Sodium Polyacrylate, Polysorbate 80,

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

Diazolidinyl Urea, Methylparaben, Iodopropynyl Butylcarbamate, Propylparaben.

STORAGE AND HANDLING

Store below 25°C (77°F)

Avoid direct sunlight.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLEXIN 
menthol and capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69695-1974
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.000375
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.05

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69695-1974-1	15 in 1 BOX
1		5 in 1 POUCH; 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	07/13/2015

Labeler - Whyteman Labs LLC (079758831)