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Pure Pain Relief

Dosage form: cream
Ingredients: Capsaicin 0.02825g in 113g
Labeler: Concept Laboratories, Inc.
NDC Code: 64058-514

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 Pain Relief™

Drug Facts

Active ingredient

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Purpose

PainRelieving

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 avoid eye contact

avoid contact with 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

for adults only apply a thin layer to affected area not more than 4 times daily

gently massage into the skin until fully absorbed wash hands with soap and water after each application to avoid spreading to sensitive mucous membranes

Other information

Excess product can be removed 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), Glyceryl Stearate SE, Glycerin, Ceteareth-20, Cetearyl Alcohol, Mineral Oil, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Petrolatum, PEG-75 Lanolin, PEG-40 Hydrogenated Castor Oil, Emu Oil, Dimethyl Sulfone, Glucosamine HCl, Propylene Glycol, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance, Blue 1

Manufactured by Concept Laboratories, Inc.
Chicago, IL 60642 (USA) www.conceptlabs.org
NDC 64058-514-34 #CL9783

PRINCIPAL DISPLAY PANEL - 113 g Jar Label

NEW!

Effective Relief

PURE RELIEF™
PAIN RELIEVING CREAM

WITH MOISTURIZING ALOE, EMU OIL & GLUCOSAMINE
NET WT. 4 OZ (113 g)

PURE PAIN RELIEF 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-514
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (Capsaicin) Capsaicin0.02825 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE 
CETOSTEARYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
PETROLATUM 
MINERAL OIL 
ISOPROPYL MYRISTATE 
EMU OIL 
GLYCERIN 
PEG-75 LANOLIN 
Water 
DIMETHYL SULFONE 
GLUCOSAMINE HYDROCHLORIDE 
ALOE VERA LEAF 
DMDM HYDANTOIN 
PROPYLENE GLYCOL 
METHYLPARABEN 
PROPYLPARABEN 
PEPPERMINT OIL 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:64058-514-34113 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/09/2013
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIOperations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-514)

Revised: 08/2013
 
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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