Label: MED O-3 BIO-- methyl salicylate, menthol, capsaicin cream

  • NDC Code(s): 83538-101-18
  • Packager: Biological M.D. Solutions LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 8, 2023

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  • ACTIVE INGREDIENTS

    METHYL SALICYLATE 10%

    MENTHOL 1%

    CAPSAICIN 0.03%

  • PURPOSE

    TOPICAL ANALGESIC

  • USES

    FAST ACTING

    DEEP PENETRATING

    HOURS OF RELIEF FOR

    • ARTHRITIS
    • BACKACHE
    • MUSCLE ACHE
    • JOINT PAIN
    • SPRAINS
    • SPORTS INJURIES
    • TENDON INFLAMMATION
    • OVER-USE INJURIES
  • 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

    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.

  • STORAGE AND HANDLING

    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

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Med 0-3 Bio-Cream_237mL

  • INGREDIENTS AND APPEARANCE
    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)
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