ClearArc by Den-Mat Holdings, LLC / Dental Technologies , Inc

ClearArc by

Drug Labeling and Warnings

ClearArc by is a Otc medication manufactured, distributed, or labeled by Den-Mat Holdings, LLC, Dental Technologies , Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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

• Adults and children 6 years and older: Use once daily after brushing.
• Apply a thin line of gel to each custom tray. Place firmly over teeth. After wearing trays for 1 minute, remove and spit out any remaining gel. Do not swallow. Do not eat or drink for 30 minutes.
• Instruct children under 12, in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
• Children under 6, consult a dentist or doctor.

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 
stannous fluoride gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59883-405
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.969 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 934 (UNII: Z135WT9208)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-405-04	113.4 g in 1 TUBE; Type 0: Not a Combination Product	07/07/2022	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/07/2022	12/31/2023

Labeler - Den-Mat Holdings, LLC (809857704)

Establishment
Name	Address	ID/FEI	Business Operations
Dental Technologies , Inc		148312838	manufacture(59883-405) , pack(59883-405) , label(59883-405)

Revised: 7/2024

Document Id: 1e6986e5-1ab5-0534-e063-6394a90a470a

34390-5

Set id: e27482fb-51b3-1f64-e053-2995a90a4dd9

Version: 3

Effective Time: 20240729