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NDC 59883-0405-04 ClearArc 0.969 mg/g Details

ClearArc 0.969 mg/g

ClearArc is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Den-Mat Holdings, LLC. The primary component is STANNOUS FLUORIDE.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 59883-0405-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	59883-0405
Product ID	59883-405_e27482fb-51b4-1f64-e053-2995a90a4dd9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ClearArc
Proprietary Name Suffix	n/a
Non-Proprietary Name	Stannous Fluoride gel
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.969
Active Ingredient Units	mg/g
Substance Name	STANNOUS FLUORIDE
Labeler Name	Den-Mat Holdings, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59883-0405-04 (59883040504)

Pricing Information	N/A
NDC Package Code	59883-405-04
Billing NDC	59883040504
Package	113.4 g in 1 TUBE (59883-405-04)
Marketing Start Date	2022-07-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e27482fb-51b3-1f64-e053-2995a90a4dd9 Details

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

INGREDIENTS AND APPEARANCE

CLEARARC

stannous fluoride gel gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/07/2022

Labeler - Den-Mat Holdings, LLC (809857704)

Name	Address	ID/FEI	Business Operations
Establishment
Dental Technologies , Inc		148312838	manufacture(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