DENTICALM- topical analgesic emulsion

DentiCalm by

Drug Labeling and Warnings

DentiCalm by is a Otc medication manufactured, distributed, or labeled by NFUSE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

NDC 82765-0043-0

Inner Primary Container Label Front and Back

NDC 82765-0043-1

INGREDIENTS AND APPEARANCE

DENTICALM 
topical analgesic emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82765-0043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82765-0043-0	1 in 1 PACKAGE	02/01/2024
1	NDC: 82765-0043-1	0.47 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/01/2024

Labeler - NFUSE LLC (063593294)