FAST ARTHRITIS AID  PAIN RELIEVING- capsaicin gel 
Concept Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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FAST ARTHRITIS AID PAIN RELIEVING GEL

Drug Facts

Active Ingredient

Capsicum Oleoresin 0.0625% (contains Capsaicin 0.025%)

Purpose

Pain Relieving

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

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)

Principal Display Panel - 57 g Bottle Label
FAST ARTHRITIS AID   PAIN RELIEVING
capsaicin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-413
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.01425 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-413-4257 g in 1 BOTTLE
2NDC:64058-413-44113 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34808/05/2011
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-413)

Revised: 1/2012
Document Id: a12868b0-0929-46bf-ba12-a2c531c184a0
Set id: 53a4935b-c7a3-41ce-b14a-983985aaa9a8
Version: 1
Effective Time: 20120119
 
Concept Laboratories, Inc.