PAINAZIN CP- capsaicin spray 
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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PAINAZIN-CP THERAPEUTIC PAIN RELIEVING SPRAY

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

Warnings

For external use only.

  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, pack, 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

Directions

Other information

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

PRINCIPAL DISPLAY PANEL - 118mL Bottle Label

NDC 64058-117-14

Painazin-CP

Therapeutic
Pain Relieving Spray
with Emu Oil, Glucosamine & MSM

Penetrating Pain Relief

Greaseless • Odorless • Stainless

4 FL OZ (118mL)

PRINCIPAL DISPLAY PANEL - 118mL Bottle Label
PAINAZIN CP 
capsaicin spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.00025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
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:64058-117-14118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/27/2011
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE

Revised: 7/2011
Document Id: 02b9d56a-ce1b-460b-8bd1-8e518a3a5484
Set id: e68893b5-e150-4f89-82dc-255ecc87b980
Version: 2
Effective Time: 20110706
 
Concept Laboratories, Inc.