Otc - Active Ingredient
Active ingredient
Menthol 4%
Myderm Cooling Menthol Pain Relief With 50 Percent More Menthol Gel
FDA Label NDC 72667-021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Inspec Solutions Llc. for the product Myderm Cooling Menthol Pain Relief With 50 Percent More Menthol (NDC 72667-021). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Menthol 4% ........... Topical analgesic
Indications & Usage
Uses Temporary relief of pain
Warnings
For external use only
Otc - When Using
DO not use in large quantities over raw surfaces and blistered area
When using this product
Use only as directed, read and follow all directions and warnings on this label, rare cases of serious burn have been reported with product of this type, do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with medicated patch, avoid contact with eyes and mucous membranes
Otc - Stop Use
Stop use and ask doctor if, condition worsens, redness is present, irritation develops, 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.
Dosage & Administration
Directions
adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor.
Inactive Ingredient
Inactive ingredients
Aloe Barbadensis Leaf Extract
Arctium Lappa Root (Burdock) Extract
Arnica Montana Flower Extract
Boswellia Carterii Resin Extract
Calendula Officinalis Extract
Camellia Sinensis Leaf Extract
Camphor
Carbomer FD&C Blue #1
FD&C Yellow #5
Full Spectrum Industrial Hemp Extract
Glycerin
Ilex Paraguariensis (Mate) Leaf Extract
Isopropyl Alcohol
Isopropyl Myristate
Melissa Officinalis (Lemon Balm) Leaf Extract
Silica
Tocopheryl Acetate
Triethanolamine
Water
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