Mamisan Ointment
FDA Label NDC 79974-216
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Miramar Cosmetics, Inc Dba Miramar Lab for the product Mamisan (NDC 79974-216). 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 drug facts, active ingredients, purpose, use, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Lidocaine HCl 4%
Menthol 1%
Purpose
Pain relieving
Use
• For the temporary relief of pain
Warnings
For external use only.
When using this product
• avoid contact with the eyes • do not use in large quantities, particularly over raw surfaces or blistered areas
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Adults and children 2 years of age and older. Apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age: Consult a doctor.
Other Information
Store in a cool, dry place 68-77°F (23-25°C)
Inactive Ingredients
BHT, D&C Red #17, D&C Yellow #11, Eucalyptus Oil, Petrolatum, Soybean Oil, Wax.
Packaging
Mamisan-216 (7997421603 4)
* Please review the disclaimer below.
