Active Ingredients
METHYL SALICYLATE 10%
MENTHOL 1%
CAPSAICIN 0.03%
Med O-3 Bio- Cream
FDA Label NDC 83538-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biological M.d. Solutions Llc for the product Med O-3 Bio- (NDC 83538-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, storage and handling, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - 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?
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