PLUS WHITE XTRA (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]

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PLUS WHITE XTRA (SODIUM MONOFLUOROPHOSPHATE) PASTE [CCA INDUSTRIES, INC.]
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NDC 61543-7237-3
Set ID f10c9011-3731-45a9-a910-a690ad25df5f
Category HUMAN OTC DRUG LABEL
Packager CCA Industries, Inc.
Generic Name
Product Class
Product Number
Application Number PART333
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  • Drug Facts

  • Active ingredient

    Sodium Monofluorophosphate 0.83% (0.11% fluoride ion)

    Purpose

    Anticavity whitening toothpaste

  • Use

    aids in the prevention of dental cavities and removal of stains

  • Warnings

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

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

  • Directions

    • adults and children 2 years and older
    • brush teeth thoroughly after each meal, or at least twice a day, or as directed by a dentist or physician
    • to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established
    • children under 2 years ask a dentist or physician
  • Inactive ingredients

  • Questions or comments?

    call Toll Free 1-800-595-6230 • www.pluswhite.com

  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    PLUS WHITE XTRA 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-7237
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61543-7237-31 in 1 BOX03/15/2019
    1100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/11/2010
    Labeler - CCA Industries, Inc. (106771041)
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