CLEARARC- stannous fluoride gel gel 
Den-Mat Holdings, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Stannous Fluoride 0.4% (0.12% w/v fluoride ion)

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities.

Warnings

This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.

Using this product may produce surface staining of the teeth. Adequate tooth brushing may prevent stains which are not harmful or permanent and may be removed by a dentist.

Keep out of reach of children section

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

For your protection, do not use if the tip under the cap is cut or tampered.

Inactive Ingredients

Ascorbc Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine

Questions or Comments?

877-9-CLEARARC

Principal Display Panel

ClearArc®

Clinical Strength

Cavity Protection Gel

Formulated with Stannous Fluoride

Mint Flavor

NET WT. 4 OZ. (113.4 G)

Labeling

ClearArc Label

CLEARARC 
stannous fluoride gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59883-405
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.969 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 934 (UNII: Z135WT9208)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59883-405-04113.4 g in 1 TUBE; Type 0: Not a Combination Product07/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/07/2022
Labeler - Den-Mat Holdings, LLC (809857704)
Establishment
NameAddressID/FEIBusiness Operations
Dental Technologies , Inc148312838manufacture(59883-405) , pack(59883-405) , label(59883-405)

Revised: 6/2022
Document Id: e27482fb-51b4-1f64-e053-2995a90a4dd9
Set id: e27482fb-51b3-1f64-e053-2995a90a4dd9
Version: 1
Effective Time: 20220627
 
Den-Mat Holdings, LLC