PURE RELIEF PENETRATING PAIN RELIEF- capsaicin gel

Pure Relief by

Drug Labeling and Warnings

Pure Relief by is a Otc medication manufactured, distributed, or labeled by Concept Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient	Purpose
Capsicum Oleoresin 0.0625%	Pain
(Containing Capsaicin 0.025%)	Relieving

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

• simple backache
• arthritis
• strains
• sprains

Warnings

For external use only.

• do not apply to wounds or damaged skin

When using this product do not get into eyes

• do not bandage tightly
• do not use with heating pad, wrap, hot water bottle or any heating element.

Stop use and ask a doctor if condition worsens

• if symptoms persist for more than 7 days
• clear up and occur again within a few days

Keep out of reach of children.

• if swallowed, get medical help or contact a Poison Control center right away
• if pregnant or nursing, seek the advice of a health professional before using

Directions

• Children under 12 years of age consult a physician
• Apply a thin layer to affected area not more than 3 to 4 times daily
• Gently massage into the skin until fully absorbed
• Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
• A burning sensation may occur upon inital application but generally disappears with continued use. For a severe burning discomfort, remove excess product with a soft cloth and cooking oil.

Inactive ingredients

Water (Aqua), Glycerin, PEG-75 Lanolin, Aloe Barbadensis Leaf Juice, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Glucosamine HCl, Medicago Sativa (Alfalfa) Extract, Ginkgo Biloba Leaf Extract, Cymbopogon Schoenanthus Extract, Seed of Celosia Argentea Extract, Dimethyl Sulfone, Panax Ginseng Root Extract, Polysorbate 20, Tocopheryl Acetate, Emu Oil, Propylene Glycol, DMDM Hydantoin. Methylparaben, Propylparaben.

Questions or comments?

Call toll-free 1-888-373-8831

SPL UNCLASSIFIED SECTION

Manufactured by:
Concept Laboratories, Inc.
Chicago, IL 60642 (USA)
#CL10010

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Pure Relief

Penetrating
Pain Relief Spray
with Capsaicin

Temporary relieves
joint & arthritis pain in

• Hips
• Knees & Elbows
• Hands & Feet
• And more

4 FL OZ (118mL)

INGREDIENTS AND APPEARANCE

PURE RELIEF   PENETRATING PAIN RELIEF
capsaicin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64058-118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM)	Capsaicin	0.0295 g  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
PEG-75 LANOLIN (UNII: 09179OX7TB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALFALFA LEAF (UNII: HY3L927V6M)
CYMBOPOGON SCHOENANTHUS LEAF (UNII: XF54B1Z2HF)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
GINKGO (UNII: 19FUJ2C58T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EMU OIL (UNII: 344821WD61)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASIAN GINSENG (UNII: CUQ3A77YXI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64058-118-14	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/06/2013

Labeler - Concept Laboratories, Inc. (962282612)

Establishment
Name	Address	ID/FEI	Business Operations
Concept Laboratories, Inc.		962282612	MANUFACTURE(64058-118)