ClearArc

Manufacturer
Den-Mat Holdings, LLC | Dental Technologies , Inc
Effective date
2022-06-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:57:21

Label at a glance#

ProductClearArc
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Indications and uses

Aids in the prevention of dental cavities.

Dosage and administration

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 supervi...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

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

OTC - 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

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

DESCRIPTION SECTION

877-9-CLEARARC

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ClearArc®

Clinical Strength

Cavity Protection Gel

Formulated with Stannous Fluoride

Mint Flavor

NET WT. 4 OZ. (113.4 G)

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ClearArc LabelClearArc Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59883-40559883-405-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1e6986e5-1ab5-0534-e063-6394a90a470ae27482fb-51b3-1f64-e053-2995a90a4dd92024-07-29WarningsExact identifier
spl set id: e27482fb-51b3-1f64-e053-2995a90a4dd9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.