PAINKOOLERS TOPICAL ANALGESIC PATCH- menthol and capsaicin patch

PainKoolers Topical Analgesic Patch by

Drug Labeling and Warnings

PainKoolers Topical Analgesic Patch by is a Otc medication manufactured, distributed, or labeled by GA Health and Beauty (FOSHAN) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Menthol 5.00%
Capsaicin 0.05%

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.
• 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 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

INGREDIENTS AND APPEARANCE

PAINKOOLERS TOPICAL ANALGESIC PATCH 
menthol and capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70118-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70118-001-05	5 in 1 POUCH
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	09/21/2015

Labeler - GA Health and Beauty (FOSHAN) Co., Ltd (544333811)