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Pure Relief Penetrating Pain Relief

Medically reviewed on February 12, 2018

Dosage form: gel
Ingredients: Capsaicin 0.0295g in 118mL
Labeler: Concept Laboratories, Inc.
NDC Code: 64058-118

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.

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

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

For external use only.

  • do not apply to wounds or damaged skin

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
  • 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
  • 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.

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

  • Hips
  • Knees & Elbows
  • Hands & Feet
  • And more

4 FL OZ (118mL)

PURE RELIEF   PENETRATING PAIN RELIEF
capsaicin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-118
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (Capsaicin) Capsaicin0.0295 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
PEG-75 LANOLIN 
DIMETHYL SULFONE 
ALOE VERA LEAF 
ALFALFA LEAF 
CYMBOPOGON SCHOENANTHUS LEAF 
GLUCOSAMINE HYDROCHLORIDE 
GINKGO 
POLYSORBATE 20 
EMU OIL 
DMDM HYDANTOIN 
PROPYLENE GLYCOL 
METHYLPARABEN 
PROPYLPARABEN 
TROLAMINE 
.ALPHA.-TOCOPHEROL ACETATE 
ASIAN GINSENG 
Packaging
#Item CodePackage Description
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/FEIOperations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-118)

 
Concept Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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