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  5. Label Information: Denticalm

FDA Label for Denticalm

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. USAGE
    3. WARNINGS
    4. KEEP OUT OF REACH OF CHILDREN.
    5. DIRECTIONS
    6. INACTIVE INGREDIENTS
    7. PURPOSE
    8. DOSAGE & ADMNISTRATION
    9. OUTER PACKAGE
    10. INNER PRIMARY CONTAINER LABEL FRONT AND BACK

Denticalm Product Label

The following document was submitted to the FDA by the labeler of this product Nfuse Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Menthol 2% Purpose: Topical Analgesic


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.


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


Outer Package



NDC 82765-0043-0


Inner Primary Container Label Front And Back



NDC 82765-0043-1


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