Label: SHOPKINS BRUSH BUDDIES- sodium fluoride paste

  • 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 December 31, 2019

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  • PURPOSE

    Anticavity

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental digestion seek professional assistance or contact a poison control center immediately.

  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Sodium Fluoride 0.243% (0.15% w/v fluoride ion) ......................... Anticavity

  • INDICATIONS & USAGE

    Helps protect teeth and roots against cavities

  • WARNINGS

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

    If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately

  • INACTIVE INGREDIENT

    Sorbitol, Silica, Aqua, PEG-32, Xylitol, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD & C Blue #1, FD &C Red # 40

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years and older:
    Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
    Do not swallow
    To minimize swallowing use a pea-sized amount in children under 6 years of age.
    Supervise children's brushing until good habits are established.
    Children under 2 years of age: Ask a dentist.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SHOPKINS BRUSH BUDDIES 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-005
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL (UNII: S8TT5K3C8Y)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorblue (F D & C Blue #1) , red (FD &C Red #4) Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-005-01119 g in 1 TUBE; Type 0: Not a Combination Product07/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/22/2016
    Labeler - Ashtel Studios Inc. (148689180)
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