Label: KIDS CREST ADVANCED FLUORIDE ANTICAVITY COLOR CHANGING- stannous fluoride paste, dentifrice

  • NDC Code(s): 69423-896-29, 69423-896-42, 69423-896-85
  • Packager: The Procter & Gamble Manufacturing Company
  • 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 November 30, 2022

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  • Drug Facts

    Active ingredient

    Stannous fluoride 0.454%

    (0.15% w/v fluoride ion)

  • Purposes

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • Warning

    Keep out of reach of children under 6 yrs. 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 yrs. of age and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist

    • do not swallow

    • to minimize swallowing use a pea-sized amount in children under 6 yrs.

    • supervise children's brushing until good habits are established

    • children under 2 yrs.: ask a dentist

  • INACTIVE INGREDIENT

    sorbitol, water, hydrated silica, sodium lauryl sulfate, cellulose gum, flavor, sodium phosphate, trisodium phosphate, mannitol, sodium saccharin, carbomer, silica, titanium dioxide, red 30 lake, blue 1

  • QUESTIONS

    Questions? 1-800-594-4158

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • KIDS Crest Advanced Color Changing

    KIDS BRUSH UP TO 2X LONGER

    KID'S Crest® ADVANCED

    FLUORIDE ANTICAVITY TOOTHPASTE

    NET WT 4.2 OZ (119 g)

    3+ yrs

    COLOR CHANGING

    I CHANGE BLUE TO PINK WHEN CLEANING

    BUBBLEGUM

    Kids Color Change

  • INGREDIENTS AND APPEARANCE
    KIDS CREST  ADVANCED FLUORIDE ANTICAVITY COLOR CHANGING
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-896
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    MANNITOL (UNII: 3OWL53L36A)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-896-8524 g in 1 TUBE; Type 0: Not a Combination Product01/01/2023
    2NDC:69423-896-291 in 1 CARTON01/01/2023
    282 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:69423-896-421 in 1 CARTON01/01/2023
    3119 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Procter & Gamble Manufacturing México, S. de R.L. de C.V.812807550manufacture(69423-896)
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