AMERIPATCH- menthol and capsaicin patch 
Meds Direct Rx, Inc.

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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AmeriPatch (69418-003)

ACTIVE INGREDIENTS:

Menthol 5.00%
Capsaicin 0.0375%

Analgesic/Counterirritant
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:

Keep out of reach of children.

Consult Physician for children under 12.

DIRECTIONS:

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

OTHER INGREDIENTS:

Water, Glycerine, Sodium Polyacrylate, Polyscorbate 80, Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt, Diaxolidinyl Urea, Methylparaben, Iodoproynyl Butylcarbamate, Propylparaben.

Package Label - AmeriPatch (69418-003-15)

FrontBack

AMERIPATCH 
menthol and capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69418-003
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) CAPSAICIN0.0375 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69418-003-153 in 1 BOX
15 in 1 POUCH
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 finalpart34801/31/2015
Labeler - Meds Direct Rx, Inc. (064053428)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co. Ltd529128763manufacture(69418-003)

Revised: 11/2015
Document Id: 24d867c0-ac2a-683c-e054-00144ff8d46c
Set id: 0de1b20b-39a5-1302-e054-00144ff88e88
Version: 10
Effective Time: 20151118
 
Meds Direct Rx, Inc.