Label: CLEARARC- stannous fluoride gel gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 27, 2022

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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 Label

  • INGREDIENTS AND APPEARANCE
    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)
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