AFLEXERYL-MC- menthol and capsaicin patch 
Easy Distributors, 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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Aflexeryl-MC Patch

ACTIVE INGREDIENTS

Menthol                     5.00%

Capsaicin                   0.0375%

PURPOSE

Topical Analgesic

External Analgesic

USES

For temporary relief of aches and pains of the muscles and joints associated with, simple backache, arthritis, strains, bruises and sprains.

Warnings:

• For external use only. Use only as directed.

• Avoid contact with eyes and mucous membranes.

• Do not apply to open wounds or damaged skin.

  • Do not use in combination with any external heat source.
  • Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.
  • Do not use if allergic to Menthol.

  • Stop use and consult physician if symptoms worsen or persist for more than 7 days.

  • Stop use if itching to excessive skin irritation occurs.

  • If pregnant or breast feeding, contact physician prior to use.

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

Directions:

• Adults and children 12-years and over: Apply to affected area; change patch 1-2 times daily.

• Children under 12, consult a physician before use.

• How to Apply:

   Clean and dry affected area.

   Remove patch from backing and apply directly to area of pain.

   Do not apply to affected area more than three times daily.

   Use only on patch at a time.

   Wash hands with soap and water immediately after application.

   Reseal pouch containing unused patches.

Other Ingredients:

Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Polysorbate-80, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodium Salt, Diazolidinyl Urea, Methyl Paraben, Iodopropynyl Butylcarbamate, Propyl Paraben.

Store at room temperature. Avoid direct sunlight

Distributed by:

Easy Distributors, LLC

15300 Jog Road Ste # 208

Delray Beach, FL 33446

Package Label

Aflexeryl-MC PATCH

(Menthol 5% / Capsaicin 0.0375%)

Qty 15 Patches

FrontMC

BackMC

AFLEXERYL-MC 
menthol and capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69532-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RACEMENTHOL (UNII: YS08XHA860) (RACEMENTHOL - UNII:YS08XHA860) RACEMENTHOL5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69532-002-1515 in 1 BOX01/14/201501/05/2016
18 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/14/201501/05/2016
Labeler - Easy Distributors, LLC (079674338)
Establishment
NameAddressID/FEIBusiness Operations
SmartData (Suzhou) Co., Ltd.529507479manufacture(69532-002)

Revised: 1/2016
 
Easy Distributors, LLC