Label: AUTOBRUSH WATERMELON- sodium fluoride liquid

  • NDC Code(s): 82913-003-01
  • Packager: Lander Enterprises, LLC
  • 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 July 18, 2023

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  • Active Ingredient

    Sodium Fluoride 0.24%

  • Purpose

    Anticavity

  • Uses

    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 Central right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    ● Adults and children 2 years of age and older: Brush teeth thoroughly, preferably
    after each meal or at least twice per day, or as directed by a dentist or physician.
    ● Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
    ● Shake before use.
    ● Squirt two times into your mouth and start brushing.
    ● Supervise children as necessary until capable of using without supervision.
    ● Children under 2 years of age: consult a dentist or physician.

  • Inactive Ingredients

    Aqua, Glycerin, Sorbitol, Poloxamer, Xylitol, Natural Watermelon Flavor, Nano Silver, Potassium Sorbate, Stevioside, Citric Acid, Calcium Citrate

  • ● Questions?

    • Email Support: customercare@autobrush.com

    ●   Phone Support: 1-888-468-7404

  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    AUTOBRUSH WATERMELON 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82913-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SILVER (UNII: 3M4G523W1G)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CALCIUM CITRATE (UNII: MLM29U2X85)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82913-003-011 in 1 CARTON12/01/2022
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/01/2022
    Labeler - Lander Enterprises, LLC (068619221)
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