MED O-3 BIO-- 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) - Med O-3 Bio-Cream (83538-101)

ACTIVE INGREDIENTS

METHYL SALICYLATE 10%

MENTHOL 1%

CAPSAICIN 0.03%

PURPOSE

TOPICAL ANALGESIC

USES

FAST ACTING

DEEP PENETRATING

HOURS OF RELIEF FOR

WARNINGS

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.

FOR TEMPORARY RELIEF.

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. USE ONLY AS DIRECTED.

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.

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

INACTIVE INGREDIENTS

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

QUESTIONS?

EMAIL US AT CONTACT@MEDBIOCREAM.COM

01b LBL_Med 0-3 Bio-Cream_237mL

MED O-3 BIO- 
methyl salicylate, menthol, capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83538-101
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
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BORAGE OIL (UNII: F8XAG1755S)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
EDETATE SODIUM (UNII: MP1J8420LU)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
WATER (UNII: 059QF0KO0R)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83538-101-18237 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: 8/2023
Document Id: 02707552-03da-3ad2-e063-6294a90a3472
Set id: 02707552-03d9-3ad2-e063-6294a90a3472
Version: 1
Effective Time: 20230808
 
Biological M.D. Solutions LLC