FDA.reportPublic FDA data

REZIL

Manufacturer
Toqara, Inc.
Effective date
2011-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:02

Label at a glance#

ProductREZIL
Active ingredientCAPSAICIN
Label structure10 sections

Indications and uses

USES: FOR TEMPORARY RELIEF OF MINOR ACHES, AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, STRAINS, SPRAINS, AND BRUISES.

Dosage and administration

DIRECTIONS: ADULTS AND CHILDREN OVER 6 YEARS OF AGE - APPLY TO AFFECTED AREA AND RUB GENTLY UNTIL ABSORBED. DO NOT USE MORE THAN 3 OR 4 TIMES DAILY.

Storage and handling

OTHER INFORMATION: STORE AT ROOM TEMPERATURE

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS SECTION

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS

CAPSAICIN 0.025%

PURPOSE SECTION

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP AWAY FROM CHILDREN.

INDICATIONS AND USES SECTION

INDICATIONS & USAGE SECTION

USES: FOR TEMPORARY RELIEF OF MINOR ACHES, AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, STRAINS, SPRAINS, AND BRUISES.

WARNINGS SECTION

WARNINGS: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. IF CONDITION WORSEN, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS, OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE A CONSULT A PHYSICIAN. DO NOT APPLY TO WOUNDS OR DAMAGED SKIN. DO NOT BANDAGE TIGHTLY.

DOSAGE AND ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: ADULTS AND CHILDREN OVER 6 YEARS OF AGE - APPLY TO AFFECTED AREA AND RUB GENTLY UNTIL ABSORBED. DO NOT USE MORE THAN 3 OR 4 TIMES DAILY.

INACTIVE INGREDIENTS SECTION

INACTIVE INGREDIENT SECTION

ISOHEXADECANE, MINERAL OIL AND DIMETHICONE

QUESTIONS OR COMMENTS SECTION

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS? 1-800-000-0000 OR GO TO WWW.TOQARA.COM

OTHER INFORMATION SECTION

STORAGE AND HANDLING SECTION

OTHER INFORMATION: STORE AT ROOM TEMPERATURE

PACKAGE LABEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REZIL PAIN RELIEF LOTION ROLL-ON

PENETRATING PAIN RELIEF FOR ARTHRITIS, STRAINS, SPRAINS AND BRUISES

NET 3 FLUID OZ./88ML  MANUFACTURED FOR TOQARA, INC. LAKEWOOD, CO 80214

REZIL LABEL
REZIL LABEL











REZIL PAIN RELIEF LOTION ROLL-ON  PENETRATING PAIN RELIEF FOR ARTHRITIS, STRAINS, SPRAINS AND BRUISES
HANDY POCKET/PURSE SIZE ROLL-ON  READ BACK OF CARD FOR FULL DETAILS  RETAIN INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS 
NET 1/4 FLUID OX./7.4 ML.
MANUFACTURED FOR:TOQARA, INC. LAKEWOOD, CO 80214 USA, 303-205-9032  WWW.REZIL.COM

REZIL PRODUCT LABELREZIL PRODUCT LABEL


REZIL FRONT LABELREZIL FRONT LABEL

REZIL BACK LABELREZIL BACK LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198556capsaicin 0.025 % Topical LotionPSN1
198556capsaicin 0.25 MG/ML Topical LotionSCD1
198556capsaicin 0.025 % Topical LotionSY1

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
76468-121-012019-11-13C16284748780-197449f38-c497-f6ea-e053-dbdaa90aa7032b7e8717-2179-4644-9414-ab596c32028a
76468-121-042019-11-13C16284748780-197449f38-c497-f6ea-e053-dbdaa90aa7032b7e8717-2179-4644-9414-ab596c32028a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76468-121-01REZIL7.4 mL in 1 BOTTLE, WITH APPLICATORLOTION7.41
76468-121-04REZIL88 mL in 1 BOTTLE, WITH APPLICATORLOTION881

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76468-121REZIL (CAPSAICIN) LOTION [TOQARA, INC.]1Legacy NDC, 2 package rows20111107_2b7e8717-2179-4644-9414-ab596c32028a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZM1
CAPSAICINACTIVE MOIETYS07O44R1ZM1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76468-12176468-121-04, 76468-121-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPSAICINS07O44R1ZMACTIB
ISOHEXADECANE918X1OUF1EIACT
MINERAL OILT5L8T28FGPIACT
DIMETHICONE92RU3N3Y1OIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates

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
460dfdb8-48a4-4980-9180-a47a550470682b7e8717-2179-4644-9414-ab596c32028a2011-09-28WarningsExact identifier
spl id: 460dfdb8-48a4-4980-9180-a47a55047068
spl set id: 2b7e8717-2179-4644-9414-ab596c32028a

Reported adverse events (FAERS/openFDA)#

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