DENTICALM- topical analgesic emulsion 
NFUSE LLC

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DentiCalm Massaging Roll On

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

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)

Revised: 2/2024
Document Id: 105c4120-51d8-bba5-e063-6294a90ae618
Set id: d677e600-f409-43bd-983e-ddfc96e9d899
Version: 2
Effective Time: 20240201
 
NFUSE LLC