Label: SALIVEA- fluoride toothpaste paste, dentifrice

  • 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 11, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Sodium Monofluorophosphate (0.14% w/v fluoride ion)

  • PURPOSE

    Anticavity

  • USES

    Aids in the prevention of dental cavities.

  • WARNINGS

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

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • 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 dentist or doctor.
    • To minimize swallowing for children under 6, use a pea-size amount and supervise brushing until good habits are established. Children under 2 years ask a dentist or physician.
  • OTHER INFORMATION

    Store at Room Temperature.

  • INACTIVE INGREDIENTS

    Sorbitol, Glycerin, Calcium Pyrophosphate, Water, Hydrated Silica, Xylitol, Silica, Hydroxyethylcellulose, Isoceteth-20, Cellulose Gum, Flavor, Sodium Benzoate, Lactoperoxidase, Potassium Thiocyanate, Glucose Oxidase, Lysozyme, Lactoferrin, Dextranase, Calcium Lactate.

  • QUESTIONS

    Questions? Comments? Call toll-free: 1-877-522-5333

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    SALIVEA DRY MOUTH CARE TOOTHPASTE

    Soothing Mint

    with Xylitol & Calcium

    image of carton

  • INGREDIENTS AND APPEARANCE
    SALIVEA 
    fluoride toothpaste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54897-701
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    MINT (UNII: FV98Z8GITP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LACTOPEROXIDASE BOVINE (UNII: 01UIN5OC49)  
    POTASSIUM THIOCYANATE (UNII: TM7213864A)  
    GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
    LYSOZYME (UNII: 968JKA7T33)  
    LACTOFERRIN, BOVINE (UNII: KG21X1090A)  
    DEXTRANASE PENICILLIUM (UNII: N2161X1O5O)  
    CALCIUM LACTATE (UNII: 2URQ2N32W3)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54897-701-13121.9 g in 1 TUBE; Type 0: Not a Combination Product02/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/19/2018
    Labeler - Laclede, Inc. (098835994)
    Registrant - Laclede, Inc. (098835994)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laclede, Inc.098835994manufacture(54897-701)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!