Active Ingredient
Methyl Salicylate 14.0%
Menthol 3.0%
Banalg
FDA Label NDC 21695-440
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Banalg (NDC 21695-440). 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 ingredient, uses, warnings, directions, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For the temporary relief of minor ach3es and pains of muscles and joints associated with arthritis and rheumatism. Also good for simple backache, strains and sprains.
Warnings
Use only as directed. If pain persists more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult your physician immediately. Discontinue use if excessive irritation of the skin develops. Avoid getting into the eyes or on mucous membranes.
For external use only. Use only as directed. Do not apply to wounds, broken or irritated skin. Do not use with a heating pad. Do not bandage tightly.
If swallowed, induce vomiting and contact a physician or poison control center immediately.
Directions
Apply fast vanishing lotion with gentle massage to affected area not more than 3 to 4 times daily.
Package/Label Principal Display Panel
Banalg Hospital Strength (5b4c09e6 4228 47d5 B8f2 5959f8aede38 01)
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