Active Ingredients
Menthol 0.24% Topical Analgesic
Lubracane Gel
FDA Label NDC 72235-5838
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ozeion Llc for the product Lubracane (NDC 72235-5838). 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, indications & usage, uses, warnings, do not use, precautions, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with arthritis and minor injuries including sprains, strains and bruises.
Warnings
For external use only. Avoid contact with eyes and open wounds. Do not use if allergic to any of its ingredients.
Keep out of reach of children. If swallowed, get medical help or contact Poison Control immediately.
Do Not Use
If pregnant, breast feeding or intending to become pregnant.
Precautions
Stop use and consult a physician if pain persists beyond 3 days, a rash or irritation develops, or if condition worsens, or resolves and then returns.
Directions
Adults and Children over 12. Apply an adequate amount of gel to cover affected area. On day 1 apply 2 to 3 times within the first hour, and up to six times that day. On the following days, apply 3 to 4 times a day, as needed.
Inactive Ingredients
Filtrated deionized water, MethylSulfonylMethane (MSM), Acrylates/C-10-30, Alkyl Acrylate Crosspolymer, Polysorbate-20, Propylene Glycol (and) Dizolidinyl Urea (and) Iodopropynyl Butylcarbamate, Ammonium Hydroxide.
Other Information
Store between 68° and 74°F (20°-23°C) with closed cover. Do not apply with hot pack.
Questions Or Comments
Email us at: [email protected]
Label
Label (Lubracane Label Live2)
Image Description (Lubracane Squarebox Live 2)
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