PAINKOOLERS- menthol, capsaicin patch

PainKoolers by

Drug Labeling and Warnings

PainKoolers by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS:

Menthol  5.00%

Capsaicin 0.0375%

Purpose

Analgesic/Counterirritant

External Analgesic

USES:

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

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.
• in combination with any other external analgesic products.
• in combination with any external heat source.
• on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.
• if you are allergic to Menthol.

Keep out of reach of children.

Consult physician for children under 12.

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.
• if rash, itching or excessive skin irritation occurs.

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 the area of pain
• Apply to affected area not more than 3 times daily
• Wash hands with soap after applying patch
• Reseal pouch containing unsed patches

OTHER INGREDIENTS:

Water, Glycerine, Sodium Polyacrylate, Polysorbate 80Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcabamate, Propylparaben.

Store

 below 25 degrees.  Avoid direct sunlight.

Product Label

PainKoolers Topical Analgesic patch Menthol 5% Capsaicin 0.0375% Designed for better mobility 5 Patches

INGREDIENTS AND APPEARANCE

PAINKOOLERS 
menthol, capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-828
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)
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: 65121-828-05	5 in 1 BOX	02/10/2017
1		8 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	12/30/2014

Labeler - Pure Source, LLC (080354456)