AMERI PATCH - menthol, capsaicin patch 
Zhejiang Bangli Medical Products Co., Ltd

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

ACTIVE INGREDIENTS:

Menthol                    5.00 %

Capsaicin                  0.0375%


Menthol      5.00 %      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, muscle soreness and stiffness.

WARNINGS:

  • For external use only. Use only as directed. Avoid contact with eyes and mucus membranes.
  • Do not cover with bandage.
  • Do not use on wounds or damaged skin.
  • Keep out of reach of children. Consult Physician for children under 12.
  • Do not use if you are allergic to Menthol.
  • Stop use ad ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.
  • or a rash, itching or excessive skin irritation occurs.

Keep out of reach of children. Consult Physician for children under 12.

DIRECTIONS:

  • Adults and children 12 years and over apply directly to affected area; change patch 1 to 2 times daily.
  • Children under 12 years, consult 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 and water after applying patch
    • Reseal pouch containing unused patches

OTHER INGREDIENTS:

Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Aloe

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

Diazolidinyl Urea, Methylparaben, Iodopropynyl Butylcarbamate,

Propylparaben

Store below 25 degrees

Avoid direct sunlight.

copy of label

AMERI PATCH  
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57900-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.0375 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
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:57900-007-0115 in 1 BOX03/15/201509/01/2016
115 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 finalpart34803/15/201509/01/2016
Labeler - Zhejiang Bangli Medical Products Co., Ltd (421295875)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Bangli Medical Products Co., Ltd421295875manufacture(57900-007)

Revised: 9/2016
 
Zhejiang Bangli Medical Products Co., Ltd