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| Product NDC Code | 82765-0043 | ||||
|---|---|---|---|---|---|
| Drug Name | Denticalm |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | EMULSION | ||||
| Application Number | M017 | ||||
| Labeler Name | NFUSE LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 2% Purpose: Topical Analgesic
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Usage Temporary relief from minor aches and pains of sore muscles and joints associated with teeth grinding and clenching (bruxism)
Purpose
Information about the drug product’s indications for use.Purpose Purpose: Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.DentiCalm Topical Analgesic WATER MAGNESIUM CHLORIDE PROPANEDIOL PEG-40 CASTOR OIL THEANINE EUCALYPTUS GLOBULUS LEAF ALOE VERA LEAF ILEX PARAGUARIENSIS LEAF BOSWELLIA SERRATA WHOLE ARCTIUM LAPPA ROOT OIL THYMUS MASTICHINA FLOWERING TOP OIL 1,2-HEXANEDIOL CAPRYLHYDROXAMIC ACID MENTHOL MENTHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Outer Package NDC 82765-0043-0 Outer Packaging
Inner Primary Container Label Front and Back NDC 82765-0043-1 Inner Primary Container front and back
Instructions for use
Information about safe handling and use of the drug product.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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. Keep out of reach of children.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API