OPRAVA- methyl salicylate, menthol, capsaicin cream 
Biological M.D. Solutions LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BIOLOGICAL MD SOLUTIONS (as PLD) - OPRAVA (83538-102)

ACTIVE INGREDIENTS

METHYL SALICYLATE 10%

MENTHOL 1%

CAPSAICIN 0.03%

PURPOSE

FOR TEMPORARY PAIN RELIEF

USES

TEMPORARILY RELIEVES

WARNING

FOR EXTERNAL USE ONLY.

USE ONLY AS DIRECTED.

NOT FOR USE IN CHILDREN UNDER 12 YEARS OF AGE.

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

DIRECTIONS

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

PDP

DF1

DF2

OPRAVA 
methyl salicylate, menthol, capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83538-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.03 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83538-102-18237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/08/2023
Labeler - Biological M.D. Solutions LLC (118991463)

Revised: 9/2023
Document Id: 055513db-1547-cadf-e063-6394a90abc5d
Set id: 05552560-e283-5eba-e063-6294a90a65f7
Version: 1
Effective Time: 20230914
 
Biological M.D. Solutions LLC