Label: PLUS WHITE EXTRA WHITENING- sodium monofluorophosphate gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 26, 2019

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  • Active Ingredient



    Sodium Monofluorophosphate 0.83%  (0.11% w/v fluoride ion)                           

  • Purpose

    Anticavity Toothpaste

  • Uses

     Aids in the prevention of dental cavitites.

  • Warnings

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

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

  • 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
    • instruct under 6 years of age in good brushing and rinse habits (it minimizes swallowing), and only use a pea size amount.
    • Children under 2 years ask a dentist or physician
  • INACTIVE INGREDIENT

    Inactive ingredients Sorbitol, Hydrated Silica, Glycerin, Water (Purified), PEG 32, Flavor, Sodium lauryl Sulfate, PVM/MA Copolymer, Flavor, Cellulose Gum, Trisodium Phosphate, Sodium Phosphate, Sodium Saccharin, Blue 1, yellow 10

  • QUESTIONS

    Questions or comments? Call Toll Free1-800-595-6230
    - www.pluswhite.com

  • Principal Display Panel -Tube 3.5 oz

    Plus+White
    Extra Whitening Gel TOOTHPASTE

    Net Wt 3.5 oz (100G) - Fluoride Anticavity Toothpaste

    Principal Display Panel -Tube 3.5 oz

  • Principal Display Panel - Carton 3.5 oz

    Plus + White 

    Extra Whitening Gel Toothpaste 

    NET WT 3.5 oz (100G) Fluoride Anticavity Toothpaste 

    Principal Display Panel - Carton 3.5 oz

  • INGREDIENTS AND APPEARANCE
    PLUS WHITE EXTRA WHITENING 
    sodium monofluorophosphate gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-1606
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.83 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    TRISODIUM DIPHOSPHATE (UNII: AR7OGW33N1)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61543-1606-31 in 1 CARTON01/31/2018
    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 finalpart35501/31/2018
    Labeler - CCA Industries, Inc. (106771041)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(61543-1606)
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