Active Ingredients
METHYL SALICYLATE 10%
MENTHOL 1%
CAPSAICIN 0.03%
Oprava Cream
FDA Label NDC 83538-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biological M.d. Solutions Llc for the product Oprava (NDC 83538-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warning, otc - keep out of reach of children, directions, storage and handling, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
FOR TEMPORARY PAIN RELIEF
Uses
TEMPORARILY RELIEVES
- ARTHRITIS
- MUSCLE PAIN
- INFLAMMATION
Warning
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
KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.
Directions
- 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).
Inactive Ingredients
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
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