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Flexin

Medically reviewed on November 13, 2017

Dosage form: patch
Ingredients: CAPSAICIN 0.0003751, MENTHOL 0.051
Labeler: Whyteman Labs LLC
NDC Code: 69695-1974

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.

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 :
  • 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.

Store below 25°C (77°F)

Avoid direct sunlight.

PRINCIPAL DISPLAY PANEL

FLEXIN 
menthol and capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69695-1974
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.000375 
MENTHOL (MENTHOL) MENTHOL0.05 
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 80 
EDETIC ACID 
WATER 
GLYCERIN 
SODIUM POLYACRYLATE (8000 MW) 
ALOE VERA LEAF 
IODOPROPYNYL BUTYLCARBAMATE 
PROPYLPARABEN 
DIAZOLIDINYL UREA 
METHYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:69695-1974-115 POUCH in 1 BOX
15 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/13/2015
Labeler - Whyteman Labs LLC (079758831)

 
Whyteman Labs LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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