Label: FRESHENUP FLUORIDE FRESH MINT- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 14, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (Total Fluoride Content - 1000 ppm approx)

  • Purpose

    Anticavity

  • Use

    regular brushing with fluoride toothpaste helps protect teeth against cavities

  • Warnings

    Keep out of the reach of children

    Keep out of the reach of children under 6 years of age. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

  • Directions

    adults and children 2 years and olderbrush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician
    children under 6 yearsto minimize swallowing use a pea sized amount and supervise brushing until good habits are established
    children under 2 yearsask a dentist or physician

  • Inactive ingredients

    Calcium Carbonate, Sorbitol, Aqua, Silica, Sodium Lauryl Sulphate, Flavour, Sodium Silicate, Tetra Sodium Pyrophosphate, Cellulose Gum, Xanthan Gum, Benzyl Alcohol, Sodium Saccharin, Sodium Benzoate, Tetra Potassium Pyrophosphate

  • SPL UNCLASSIFIED SECTION

    Plaque ShieldTM​ is a trademarks of healthy + KIND Co.

    freshenup​ is a licensed trademark of healthy+KIND Co. Made In India. All rights reserved

  • PRINCIPAL DISPLAY PANEL

    NDC 52553-050-02

    ANTICAVITY

    Freshenup

    FLUORIDE TOOTHPASTE

    FRESH MINT

    SENSITIVE + GENTLE

    TARTAR + GUM HEALTH

    Fight Gengivitis

    Plaque ShieldTM

    Aid in Breath Control

    NET WT 3.5 OZ (99.2 g)

    Label

  • INGREDIENTS AND APPEARANCE
    FRESHENUP FLUORIDE FRESH MINT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52553-050
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) fluoride ion7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52553-050-021 in 1 CARTON08/14/2019
    199.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/14/2019
    Labeler - U. S. Nonwovens Corp (847061520)
    Registrant - U. S. Nonwovens Corp (847061520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dabur India Limited650599231manufacture(52553-050)
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