Label: BEAM- sodium fluoride 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 November 29, 2018

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

  • Active ingredient

    Sodium Fluoride 0.243% (0.16% w/v fluoride ion)

  • 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 accidently swallowed, get medical help or contact a Poison Control Center right away.

  • 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. Instruct children under 6 years of age in good brushing and rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supevision.
    • Children under 2 years of age, constult a dentist or a doctor.
  • Other information

    For your protection, this tube has a foil seal under the cap.

  • Inactive ingredients

    kaolin clay, water, sorbicol, glycerin, sodium laurly sulfate, carboxymethyl cellulose, flavor, sodium phosphate, xylitol, bentonite clay, sucralose, menthol, sodium citrate

  • Questions or comments?

    Manufactured for Beam Technologies, Inc.

    Formulated by Dentisse, Inc.

    1 800 648 1179

    Columbus, OH 43215

    Made in USA

  • PRINCIPAL DISPLAY PANEL

    Clean Mint

    beam ®

    paste

    6 oz.

    Anticavity Fluoride

    Toothpaste

    Net Wt. 6 oz. (170g.)

    Beam_toothpaste_image.jpg

  • INGREDIENTS AND APPEARANCE
    BEAM 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70014-0703
    Route of AdministrationDENTAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70014-0703-2170 g in 1 TUBE; Type 0: Not a Combination Product11/05/2015
    2NDC:70014-0703-324 g in 1 TUBE; Type 0: Not a Combination Product11/29/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/05/2015
    Labeler - Beam (010841925)