FDA.reportPublic FDA data

Pure Relief

Manufacturer
Concept Laboratories, Inc.
Effective date
2017-02-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:48:58

Label at a glance#

ProductPure Relief
Active ingredientCapsaicin
Label structure10 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains sprains

Dosage and administration

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

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Purpose

OTC - PURPOSE SECTION

Pain Relieving

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

  • 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.

OTC - WHEN USING SECTION

When using this product avoid eye contact

  • avoid contact with mucous membranes

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • if pregnant or nursing, seek the advice of a health professional before using

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

Water (Aqua), Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Arnica Montana Flower Extract, Cymbopogon Schoenanthus Stem/Leaf/Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Linum Usitatissimum (Linseed) Seed Extract, Celosia Argentea Seed Extract, Euterpe Oleracea Fruit Extract, Mentha Piperita (Peppermint) Oil, Glucosamine HCl, Dimethyl Sulfone, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-12, Cetyl Palmitate, Emu Oil, Polysorbate 20, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide.

SPL UNCLASSIFIED SECTION

Manufactured by Concept Laboratories, Inc.
Chicago, IL 60642 (USA) www.conceptlabs.org
#CL9783-R2

PRINCIPAL DISPLAY PANEL - 113 g Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EFFECTIVE RELIEF

PURE RELIEF™
PAIN RELIEVING CREAM

WITH MOISTURIZING ALOE,
EMU OIL & GLUCOSAMINE

NET WT. 4 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Jar Label
PRINCIPAL DISPLAY PANEL - 113 g Jar Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198555capsaicin 0.025 % Topical CreamPSN2
198555capsaicin 0.25 MG/ML Topical CreamSCD2
198555capsaicin 0.025 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64058-356-342020-01-31C16284748780-19d75b9d0-55e4-f424-e053-dadaa90a57cePure Relief™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64058-356-34Pure Relief113 g in 1 JARCREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64058-356PURE RELIEF (CAPSAICIN) CREAM [CONCEPT LABORATORIES, INC.]2Legacy NDC, 1 package rows20170228_5523f9bf-6ff6-4fd3-98ff-ada1bfa03b6b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64058-35664058-356-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
CapsaicinS07O44R1ZMACTIB
Water059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYL DIISOPROPYL PROPIONAMIDE6QOP5A9489IACT
ETHYL MENTHANE CARBOXAMIDE6S7S02945HIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
LAURYL LAURATEGPW77G0937IACT
STARCH, CORNO8232NY3SJIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
ALFALFADJO934BRBDIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CYMBOPOGON SCHOENANTHUS TOP9SJI1LW39WIACT
ROSEMARYIJ67X351P9IACT
MENTHA PIPERITA LEAFA389O33LX6IACT
ASIAN GINSENGCUQ3A77YXIIACT
GINKGO19FUJ2C58TIACT
FLAX SEED4110YT348CIACT
CELOSIA ARGENTEA SEEDO1H314U8M2IACT
ACAI46AM2VJ0AWIACT
EDETATE DISODIUM7FLD91C86KIACT
EMU OIL344821WD61IACT
POLYSORBATE 207T1F30V5YHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
Ethylhexylglycerin147D247K3PIACT
Hexylene GlycolKEH0A3F75JIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETEARETH-127V4MR24V5PIACT
CETYL PALMITATE5ZA2S6B08XIACT
PEPPERMINT OILAV092KU4JHIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d066a7d8-a096-4707-9f10-7efc3e97c96c5523f9bf-6ff6-4fd3-98ff-ada1bfa03b6b2017-02-27WarningsExact identifier
spl id: d066a7d8-a096-4707-9f10-7efc3e97c96c
spl set id: 5523f9bf-6ff6-4fd3-98ff-ada1bfa03b6b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.