Label: CLOSE UP ANTICAVITY TOOTHPASTE- anticavity toothpaste gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 26, 2010

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  • ACTIVE INGREDIENT

    Drug Facts:

    Sodium Fluoride:     0.24%

    Purpose:  Anticavity Toothpaste

  • WARNINGS

    KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE.

    IF MORE THAN USED FOR BRUSHING, IS ACCIDENTALLY SWALLOWED. GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • INACTIVE INGREDIENT

    Sorbitol , Water,  Hydrated Silica, PEG-32,  Sodium Lauryl Sulfate, SD-Alcohol 38B, Flavor, Cellulose Gum, Sodium Saccharin, Red33, Red40

  • QUESTIONS

    Questions or Comments ?:  Call 1-800-786-5135 Monday -Friday 9am-5pmET

  • PRINCIPAL DISPLAY PANEL

    Image of Tube Label

  • INGREDIENTS AND APPEARANCE
    CLOSE UP ANTICAVITY TOOTHPASTE 
    anticavity toothpaste gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61047-771
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride0.54 g  in 226.8 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61047-771-11226.8 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/26/2010
    Labeler - KIK Custom Products (243547333)
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