Label: DENTEK LOONEY TUNES KIDS BUBBLEGUM BLAST- fluoride toothpaste paste, dentifrice

  • 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 February 8, 2016

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  • ACTIVE INGREDIENT

    Active Ingredients:

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

  • PURPOSE

    Purpose:

    Anticavity

  • INDICATIONS & USAGE

    Use:

    Helps protect against cavities

  • WARNINGS

    Warnings:

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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

  • DOSAGE & ADMINISTRATION

    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 a 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 INGREDIENT

    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

  • toothpaste tube label

    Looney toothpaste tube label

  • INGREDIENTS AND APPEARANCE
    DENTEK LOONEY TUNES KIDS  BUBBLEGUM BLAST
    fluoride toothpaste 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 ION0.09639 g  in 76.5 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 61.1618 g  in 76.5 g
    HYDRATED SILICA (UNII: Y6O7T4G8P9) 15.3 g  in 76.5 g
    SODIUM PHOSPHATE (UNII: SE337SVY37) 0.3825 g  in 76.5 g
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.176 g  in 76.5 g
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) 0.918 g  in 76.5 g
    ERYTHROSINE SODIUM ANHYDROUS (UNII: 8TL7LH93FM) 0.0008 g  in 76.5 g
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 1.3005 g  in 76.5 g
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.0765 g  in 76.5 g
    SORBITOL (UNII: 506T60A25R) 42.075 g  in 76.5 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60630-498-0176.5 g in 1 TUBE; Type 0: Not a Combination Product02/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/28/2014
    Labeler - DenTek Oral Care, Inc. (153818646)
    Registrant - DenTek Oral Care, Inc. (153818646)
    Establishment
    NameAddressID/FEIBusiness Operations
    DenTek Oral Care, Inc.153818646label(60630-498)
    Establishment
    NameAddressID/FEIBusiness Operations
    Goran Pharma Pvt. Ltd.862174088manufacture(60630-498)
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