Label: DENTEK KIDS ANTICAVITY FLUORIDE LOONEY TUNES BUBBLEGUM BLAST- sodium fluoride paste, dentifrice

  • NDC Code(s): 60630-498-01
  • Packager: DenTek Oral Care, Inc.
  • 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 October 1, 2013

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  • toothpaste tube label

    label for outside of tube

  • Active Ingredients

    Sodium Fluoride 0.22% (0.126% w/v Fluoride Ion)

  • Purpose

    Anticavity

  • Indications and Use

    Use: Helps protect against cavities

  • 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.

  • Directions

    .Adults and children 2 years of age and older: brush teeth thoroughly after meals or at least twice a day or use as directed by dentist  .Children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) .Children under 2 years: ask a dentist or physician

  • Inactive Ingredients

    Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Phosphate, Sodium Saccharin, Sodium Hydroxide, CI 45430 (FD&C Red No. 3).

  • Questions

    Questions? 1-800-433-6835

  • Keep Out of Reach of Children

    Keep out of reach of children under 6 years of age.

  • INGREDIENTS AND APPEARANCE
    DENTEK KIDS ANTICAVITY FLUORIDE  LOONEY TUNES BUBBLEGUM BLAST
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60630-498
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0964 g  in 76.5 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R) 42.075 g  in 76.5 g
    WATER (UNII: 059QF0KO0R) 15.34 g  in 76.5 g
    HYDRATED SILICA (UNII: Y6O7T4G8P9) 15.3 g  in 76.5 g
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 1.3 g  in 76.5 g
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 0.918 g  in 76.5 g
    SODIUM PHOSPHATE (UNII: SE337SVY37) 0.38 g  in 76.5 g
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) 0.176 g  in 76.5 g
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.0765 g  in 76.5 g
    Product Characteristics
    Colorred (CI 45430 (FD&C Red No. 3)) Score    
    ShapeSize
    FlavorBUBBLE GUM (Proprietary blend) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60630-498-0176.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/01/2014
    Labeler - DenTek Oral Care, Inc. (153818646)
    Registrant - DenTek Oral Care, Inc. (153818646)
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