ARTHRITAZIN PAIN RELIEVING- capsaicin gel 
ARTHRITAZIN PAIN RELIEVING  EZ- 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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Arthritazin™ Pain Relieving Gel

Drug Facts

Active ingredient

Capsicum Oleoresin 0.0625%
(Containing 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

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

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

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 inital 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 Acrylates Crosspolymer, Triethanolamine, Polysorbate 20, Celosia Argentea Seed Extract, Ginkgo Biloba Extract, Panax Ginseng Root Extract, Medicago Sativa (Alfalfa) Extract, Cymbopogon Schoenanthus Extract, Emu Oil, Dimethyl Sulfone, Tocopheryl Acetate, Glucosamine HCl, Propylene Glycol, DMDM Hydantoin, Methylparaben, Propylparaben.

Questions or comments?

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

Manufactured by: #CL9775
Concept Laboratories, Inc.
Chicago, IL 60642 (USA) NDC 64058-813-49

PRINCIPAL DISPLAY PANEL - 255 g Bottle Label

ArthritazinTM
Pain Relieving Gel
Moisturizing Vitamin E
Warming relief from arthritis pain
NET WT 9 OZ (255 g)

PRINCIPAL DISPLAY PANEL - 255 g Bottle Label

PRINCIPAL DISPLAY PANEL - 113 g Bottle Label

ArthritazinTM
EZ Pain Relief Gel
Soothing Massaging Applicator
Temporary relief from arthritis pain
NET WT 4 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 255 g Bottle Label

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

ArthritazinTM
Pain Relieving Gel
Eazy to use travel size
Relief from arthritis pain
NET WT 3 OZ (85 g)

PRINCIPAL DISPLAY PANEL - 255 g Bottle Label
ARTHRITAZIN PAIN RELIEVING 
capsaicin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-913
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.02125 g  in 85 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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-913-1385 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/201308/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/10/201308/01/2017
ARTHRITAZIN PAIN RELIEVING   EZ
capsaicin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.02825 g  in 113 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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-123-41113 g in 1 BOTTLE; Type 0: Not a Combination Product02/07/201308/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34802/07/201308/01/2017
ARTHRITAZIN PAIN RELIEVING 
capsaicin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-813
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.06375 g  in 255 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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-813-49255 g in 1 BOTTLE; Type 0: Not a Combination Product01/17/201308/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/17/201308/01/2017
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-913, 64058-123, 64058-813)

Revised: 10/2017
 
Concept Laboratories, Inc.