FDA.reportPublic FDA data

OPRAVA

Manufacturer
Biological M.D. Solutions LLC
Effective date
2024-01-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:54:10

Label at a glance#

ProductOPRAVA
Active ingredientMETHYL SALICYLATE, CAPSAICIN, MENTHOL
Label structure9 sections

Indications and uses

TEMPORARILY RELIEVES ARTHRITIS MUSCLE PAIN INFLAMMATION

Dosage and administration

APPLY GENEROUSLY. GENTLY MASSAGE INTO PAINFUL AREA UNTIL THOROUGHLY ABSORBED. REPEAT AS NECESSARY, UP TO FOUR TIMES DAILY. PRODUCT CAN BE USED WITH A WRAP.

Storage and handling

STORE AT CONTROLLED ROOM TEMPERATURE. 59° - 86°F (15° - 30°C).

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

METHYL SALICYLATE 10%

MENTHOL 1%

CAPSAICIN 0.03%

PURPOSE

OTC - PURPOSE SECTION

FOR TEMPORARY PAIN RELIEF

USES

INDICATIONS & USAGE SECTION

TEMPORARILY RELIEVES

  • ARTHRITIS
  • MUSCLE PAIN
  • INFLAMMATION

WARNING

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

  • AVOID CONTACT WITH EYES, MUCOUS MEMBRANES AND BROKEN OR IRRITATED SKIN.
  • IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS, OR IF REDNESS IS PRESENT, DISCONTINUE USE AND CONSULT A PHYSICIAN.

USE ONLY AS DIRECTED.

NOT FOR USE IN CHILDREN UNDER 12 YEARS OF AGE.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • APPLY GENEROUSLY.
  • GENTLY MASSAGE INTO PAINFUL AREA UNTIL THOROUGHLY ABSORBED.
  • REPEAT AS NECESSARY, UP TO FOUR TIMES DAILY.
  • PRODUCT CAN BE USED WITH A WRAP.

STORAGE AND HANDLING SECTION

STORE AT CONTROLLED ROOM TEMPERATURE. 59° - 86°F (15° - 30°C).

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ALOE VERA, VITAMINS A AND E, ANTIOXIDANTS, ALOE BARBADENSIS LEAF JUICE, BORAGE OIL, CARBOMER, CETEARYL ALCOHOL, CETYL ALCOHOL, DEIONIZED WATER, EUCALYPTUS GLOBULUS LEAF OIL, FRUCTOSE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, METHYL PARABEN, OLEA EUROPAEA (OLIVE) FRUIT OIL, PHENOXYETHANOL, POLYSORBATE-60, PROPYL PARABEN, PROPYLENE GLYCOL, SALMON OIL, SODIUM HYDROXIDE, SQUALANE, STEARYL ALCOHOL, STEARIC ACID, TETRASODIUM EDTA, TOCOPHEROL, TOCOPHERYL ACETATE, VITIS VINIFERA (GRAPE) SEED OIL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DF1DF1

DF2DF2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2644111capsaicin 0.03 % / menthol 1 % / methyl salicylate 10 % Topical CreamPSN2
2644111capsaicin 0.3 MG/ML / menthol 10 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD2
2644111capsaicin 0.03 % / menthol 1 % / methyl salicylate 10 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83538-102-182025-02-01C16284748780-12cef2736-76be-d83d-e063-dadaa90ab31fBIOLOGICAL MD SOLUTIONS (as PLD) - OPRAVA (83538-102)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83538-102-18OPRAVA237 mL in 1 BOTTLECREAM2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83538-102OPRAVA (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [BIOLOGICAL M.D. SOLUTIONS LLC]2Current NDC, 1 package rows20250202_05552560-e283-5eba-e063-6294a90a65f7.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83538-10283538-102-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLPARABENZ8IX2SC1OHIACT
POLYSORBATE 60CAL22UVI4MIACT
STEARIC ACID4ELV7Z65APIACT
BORAGE OILF8XAG1755SIACT
STEARYL ALCOHOL2KR89I4H1YIACT
EDETATE SODIUMMP1J8420LUIACT
TOCOPHEROLR0ZB2556P8IACT
METHYLPARABENA2I8C7HI9TIACT
CETYL ALCOHOL936JST6JCNIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
WATER059QF0KO0RIACT
EUCALYPTUS OIL2R04ONI662IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ATLANTIC SALMON OIL15NDG5B709IACT
SODIUM HYDROXIDE55X04QC32IIACT
OLIVE OIL6UYK2W1W1EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SQUALANEGW89575KF9IACT
FRUCTOSE6YSS42VSEVIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GRAPE SEED OIL930MLC8XGGIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
LAVENDER OILZBP1YXW0H8IACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYL SALICYLATELAV5U5022YACTIB
CAPSAICINS07O44R1ZMACTIB
MENTHOLL7T10EIP3AACTIB

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
OPRAVAMETHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC05552560-e283-5eba-e063-6294a90a65f72024-01-06WarningsExact identifier
ndc (package): 83538-102-18
ndc (product): 83538-102
ndc11 (package): 83538010218
spl id: 0e49fac4-c067-beb0-e063-6294a90ac96f
spl set id: 05552560-e283-5eba-e063-6294a90a65f7

Reported adverse events (FAERS/openFDA)#

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