AMERIPATCH- menthol and capsaicin patch

AmeriPatch by

Drug Labeling and Warnings

AmeriPatch by is a Otc medication manufactured, distributed, or labeled by Meds Direct Rx, Inc., Foshan Aqua Gel Biotech Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Menthol 5.00%
Capsaicin 0.0375%

PURPOSE

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:

• 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.
• Do not use if you are allergic to Menthol.
• Stop use and ask a doctor if conditions worsen, 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 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 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)

INGREDIENTS AND APPEARANCE

AMERIPATCH 
menthol and capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69418-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0375 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69418-003-15	3 in 1 BOX
1		5 in 1 POUCH
1		15 g in 1 PATCH; 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	01/31/2015

Labeler - Meds Direct Rx, Inc. (064053428)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co. Ltd		529128763	manufacture(69418-003)