Label: DENTAL PLUS WHITENING- sodium monofluorophosphate 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 February 24, 2021

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  • Active Ingredient

    Sodium monofluorophosphate 0.8% (1,000 ppm F)

  • Purpose

    anticavity

  • Use

    Aids in the prevention of dental cavities

  • WARNINGS

  • Ask a dentist before use if you have

    bleeding or redness lasting more than 2 weeks, pain, swelling, pus, loose teeth, or more spacing between teeth. These may be signs of periodontitis, a serious form of gum disease.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years 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 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
    • Children under 2 years of age: Consult a dentist or doctor.
  • Inactive ingredients

    water, sorbitol, calcium carbonate, silica, PEG-32, sodium lauryl sulphate, flavor, cellulose gum, sodium bicarbonate, flavor, titanium dioxide, sodium saccharin, sodium benzoate, benzoic acid, zinc citrate

  • QUESTIONS

    Questions or comments? www.sleeksensation.com

  • PRINCIPAL DISPLAY PANEL

    Dental Plus Whitening

    Anticavity Fluoride Toothpaste

    Net Wt 5.1 oz (145 g)

    Front Panel

  • INGREDIENTS AND APPEARANCE
    DENTAL PLUS WHITENING 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62685-216
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62685-216-031 in 1 BOX02/01/2021
    1145 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/01/2021
    Labeler - tropical degil cosmetics industries ltd (600437230)
    Establishment
    NameAddressID/FEIBusiness Operations
    tropical degil cosmetics industries ltd600437230manufacture(62685-216)
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