Label: ORBITOL FLUORIDE WHITENING TOOTHPASTE- sodium monofluorophosphate paste

  • NDC Code(s): 62685-232-04
  • Packager: tropical degil cosmetics industries ltd
  • 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 January 5, 2023

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  • Active ingredient

    Sodium monofluorophosphate 0.8% w/w (1000 ppm fluoride ion)

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities

  • WARNINGS

    Do not use

    Do not use if you are sensitive to any of the ingredients in this prouduct.

    When using this product

    When using this product avoid contact with eyes.

    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 6 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 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
    • Children under 6 years of age: Do not use unless directed by a dentist or doctor.
  • Inactive ingredients

    water, sorbitol, calcium carbonate, silica, peg-32, cellulose gum, sodium lauryl sulfate, sodium bicarbonate, flavor, titanium dioxide, sodium saccharin, sodium benzoate, menthyl lactate, benzoic acid, zinc citrate, limonene

  • Other information

    Other information store below 30°C (86°F).

  • Principal Display Panel

    PDP

  • INGREDIENTS AND APPEARANCE
    ORBITOL FLUORIDE WHITENING TOOTHPASTE 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62685-232
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62685-232-041 in 1 BOX09/27/2021
    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 finalpart35509/27/2021
    Labeler - tropical degil cosmetics industries ltd (600437230)
    Establishment
    NameAddressID/FEIBusiness Operations
    tropical degil cosmetics industries ltd600437230manufacture(62685-232)
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