FAST ARTHRITIS AID PAIN RELIEVING- capsaicin gel

Fast Arthritis Aid by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

Active Ingredient

Capsicum Oleoresin 0.0625% (contains Capsaicin 0.025%)

Purpose

Pain Relieving

INDICATIONS & USAGE

Uses for the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains sprains bruises

Warnings

For external use only.

do not apply to wounds or damaged skin do not bandage tightly. Do not use with heating pad, wrap, hot water bottle or any heating element.

When using this product do not get into eyes

avoid contact with other mucous membranes

Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or 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

Other information

It is recommended to test for skin sensitivity prior to use. Apply product to a small area, follow the directions and wait 24 hours. Proceed with application if no adverse reaction. A burning sensation may occur upon initial application but generally disappears with continued use. For a severe burning discomfort, remove excess product with a soft cloth and cooking oil.

If applying product to hands, wait 30 minutes before washing.

Avoid water, heat, or direct sunlight while using product.

If wearing contact lenses, insert prior to application and avoid touching them after applying product.

If eye contact occurs, flush immediately with water.

Inactive ingredients

Water (Aqua), Glycerin, PEG-75 Lanolin, Aloe Barbadensis Leaf Juice, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Polysorbate 20, Glucosamine HCl, Emu Oil, Dimethyl Sulfone, Celosia Argentea Seed Extract, Ginkgo Biloba Extract, Panax Ginseng Root Extract, Medicago Sativa (Alfalfa) Extract, Cymbopogon Schoenanthus Extract, Tocopheryl Acetate, DMDM Hydantoin, Propylene Glycol, Methylparaben, Propylparaben.

Questions or comments?

Call 1-888-373-8831 or visit www.conceptlabs.org

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Manufactured by Concept Laboratories, Inc.
Chicago, IL 60642 www.conceptlabs.org
#BG-CL9734

PRINCIPAL DISPLAY PANEL - 57 g Bottle Label

NDC: 64058-413-42

Immediate Warming Relief

For Arthritis Joint and Muscle Pain

Fast Arthritis Aid

Pain Relieving Gel

2 oz (57g)

INGREDIENTS AND APPEARANCE

FAST ARTHRITIS AID   PAIN RELIEVING
capsaicin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64058-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM)	Capsaicin	0.01425 g  in 57 g

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)
MEDICAGO SATIVA 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64058-413-42	57 g in 1 BOTTLE
2	NDC: 64058-413-44	113 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part348	08/05/2011

Labeler - Concept Laboratories, Inc. (962282612)

Establishment
Name	Address	ID/FEI	Business Operations
Concept Laboratories, Inc.		962282612	MANUFACTURE(64058-413)