OPRAVA- methyl salicylate, menthol, capsaicin cream

OPRAVA by

Drug Labeling and Warnings

OPRAVA by is a Otc medication manufactured, distributed, or labeled by Biological M.D. Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

METHYL SALICYLATE 10%

MENTHOL 1%

CAPSAICIN 0.03%

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OPRAVA 
methyl salicylate, menthol, capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83538-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.03 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARIC ACID (UNII: 4ELV7Z65AP)
BORAGE OIL (UNII: F8XAG1755S)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
EDETATE SODIUM (UNII: MP1J8420LU)
TOCOPHEROL (UNII: R0ZB2556P8)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ATLANTIC SALMON OIL (UNII: 15NDG5B709)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
OLIVE OIL (UNII: 6UYK2W1W1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SQUALANE (UNII: GW89575KF9)
FRUCTOSE (UNII: 6YSS42VSEV)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83538-102-18	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/08/2023

Labeler - Biological M.D. Solutions LLC (118991463)