Active Ingredient
Menthol 2% Purpose: Topical Analgesic
Denticalm Emulsion
FDA Label NDC 82765-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nfuse Llc for the product Denticalm (NDC 82765-0002). 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, usage, warnings, keep out of reach of children., directions, inactive ingredients, purpose, dosage & admnistration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Usage
Temporary relief from minor aches and pains of sore muscles and joints associated with teeth grinding and clenching (bruxism)
Warnings
For External Use Only
When using this product:
[bullet] Avoid contact with eyes and mucous membranes
[bullet] Do not apply to wounds or broken skin
[bullet] Do not bandage
[bullet] Do not apply to irritated skin or if excessive skin irritation develops
Stop use and ask a doctor if conditions worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Keep Out Of Reach Of Children.
Keep out of reach of children.
Directions
Shake before use. Adults and children 12 years of age and older: apply over affected areas not more than four times daily; massage as necessary. Children under 12 years of age: Consult physician.
Inactive Ingredients
Water, Magnesium Chloride USP, Propanediol, PEG-40 Hydrogenated Castor Oil, L-Theanine, Eucalyptus Globulus Leaf Oil, Aloe Barbadensis Leaf Extract, Ilex Paraguariensis Leaf Extract, Boswellia Serrata Oil, Arctium Lappa Root Extract, Thymus Mastichina Flower Oil, 1,2-Hexanediol, Caprylhydroxamic Acid
Purpose
Purpose: Topical Analgesic
Dosage & Admnistration
Shake before use. Adults and children 12 years of age and older: apply over affected areas not more than four times daily; massage as necessary. Children under 12 years of age: Consult physician.
Outer Package
NDC 82765-0002-0
Inner Primary Container Label Front And Back
NDC 82765-0002-1
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