Label: PRO CARE FLOURIDE- sodium fluoride gel

  • 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 August 10, 2020

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  • Drugs Facts:

  • Active ingredient

    Sodium fluoride 0.21%

    Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities

  • Warnings

    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.

  • Other information

    Use at least 0.04 oz (1 g) of toothpaste. Close the cap after usage. Keep away from direct sunlight for a long time.

  • Inactive Ingredients

    Cellulose Gum, Hydrate Silica, Flavor, Mica, Organic psidium guajava fruit, PEG-32, Propolis Extract, Sodium Chloride, Sodium Lauryl Sulfate, Sodium Sarcharin, Sorbitol, Troxerutin, Water, Xylitol.

  • Directions

    Adults and children 2 years of age and older. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentis or doctor.
    Children under 6 years old of age. Intruct in good brushing and rinsing habits ( to minimize swallowing) Supevise children as necessary until capable of using without supervison.
    Children under 2 years old of age. Consult a dentist or doctor.

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    PRO CARE FLOURIDE 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78989-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MICA (UNII: V8A1AW0880)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    TROXERUTIN (UNII: 7Y4N11PXO8)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78989-001-011 in 1 BOX08/05/2020
    1185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/05/2020
    Labeler - DILIGO HOLDINGS JOINT STOCK COMPANY (555365269)
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