PURE RELIEF  PENETRATING PAIN RELIEF- 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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Pure Relief
Penetrating Pain Relief Spray

Drug Facts

Active ingredientPurpose
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

Warnings

For external use only.

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

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

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

4 FL OZ (118mL)

Principal Display Panel - 118 mL Bottle Label
PURE RELIEF   PENETRATING PAIN RELIEF
capsaicin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-118
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.0295 g  in 118 mL
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-118-14118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/06/2013
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-118)

Revised: 2/2014
Document Id: 4e46efaf-2928-410f-bf14-31517a6cea19
Set id: d71b0793-0e69-4249-ac4b-d819fe2882aa
Version: 1
Effective Time: 20140211
 
Concept Laboratories, Inc.