Active Ingredient
Menthol 5%
Menthol Davis Analgesic
FDA Label NDC 82480-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Genia Care Phamaceutical S.a. for the product Menthol Davis Analgesic (NDC 82480-000). 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, purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Use
For the temporary relief of minor aches and pains of muscles and joints
Warnings
For external use only.
When Using This Product
- avoid contact with the eyes
- do not apply to wounds or damaged skin
- do not bandage tightly
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
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, ventilated place, away from all sources of heat, ignition, and combustion.
Inactive Ingredients
Paraffin wax, petrolatum.
Package Labeling:
Label (Label)
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