FESI- menthol, capsaicin patch

FESI by

Drug Labeling and Warnings

FESI by is a Otc medication manufactured, distributed, or labeled by API SOLUTIONS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Menthol                     5.00%

Capsaicin                   0.05%

PURPOSE

Topical Analgesic

Topical Analgesic

USES

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

WARNINGS

For external use only.

When using this product

• use only as directed

do not use

• on, and avoid contact with face, scalp, eyes, mouth, and mucous membranes
• do not use on wounds or damaged or sensitive skin
• do not use in combination with any external heat source (heating pad, etc.) or for 1 hour before or after bathing or showering
• do not use in combination with any compression (bandage, wrap, brace, stocking, sock, or similar device or garment)
• do not use in combination with any other external analgesic products

Stop use and ask a doctor if

• excessive redness, burning, swelling, irritation, or discomfort develops in the skin, eyes, mouth or mucous membranes
• condition worsens
• pain persists for more than 7 days
• symptoms clear up and occur again within a few days

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a doctor before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away

DIRECTIONS

• Adults and children 16 years and over

• apply directly to affected area of pain

• change patch 1 to 2 times daily, or as directed by a doctor

• children under 16 years, ask a doctor before using

  how to apply:

  - clean and dry affected area - tear open pouch and remove one patch

  - remove protective film and apply directly to affected area of pain

  - reseal pouch containing unused patches after each use

  - wash hands with soap and water after applying

OTHER INGREDIENTS:

Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, Glycerine, Iodoproynyl Butylcabamate, Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, Tetrasodium EDTA.

SPL UNCLASSIFIED SECTION

Distributed by:

A.P.I SOLUTIONS

Daphen, AL 36526

For Questions or Comments Please Call 855-878-1489

FESI Pain Relief Patch, 15 Count (

46144-941-15)

INGREDIENTS AND APPEARANCE

FESI 
menthol, capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46144-941
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	0.05 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46144-941-15	15 in 1 BOX	10/13/2014
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	10/13/2014

Labeler - API SOLUTIONS INC. (831870824)