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
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- STORAGE AND HANDLING
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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
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INGREDIENTS AND APPEARANCE
MED O-3 BIO-
methyl salicylate, menthol, capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83538-101 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83538-101-18 237 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 not final part348 08/08/2023 Labeler - Biological M.D. Solutions LLC (118991463)