Label: DENTICALM- topical analgesic emulsion

  • NDC Code(s): 82765-0043-0, 82765-0043-1
  • Packager: NFUSE LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

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  • 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.

  • 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

    Outer Packaging

    NDC 82765-0043-0

  • Inner Primary Container Label Front and Back

    NDC 82765-0043-1

    Inner Primary Container front and back

  • INGREDIENTS AND APPEARANCE
    DENTICALM 
    topical analgesic emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82765-0043
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    THEANINE (UNII: 8021PR16QO)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
    ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)  
    THYMUS MASTICHINA FLOWERING TOP OIL (UNII: 9NP0832457)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82765-0043-01 in 1 PACKAGE02/01/2024
    1NDC:82765-0043-10.47 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/01/2024
    Labeler - NFUSE LLC (063593294)
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