Label: HONEST-PASTE KIDS- dental type silica paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 7, 2022

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  • Active ingredients

    Dental type silica 8%

  • Purpose

    Anticavity

  • Use

    helps protect against cavities

  • Warnings

    When using this product, avoid contact with eyes and lips. If contact occurs, rinse with water.

  • Stop use and ask a dentist if

    irritation or redness develops.

  • Keep out of reach of children.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • children under 1 year: ask a dentist or physician
    • children under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing)
  • Inactive ingredients

    glycerin, cellulose gum, ascorbic acid, rosemary extract, scutellaria root extract, green tea extract, xylitol, calendula extract, chamomile extract, enzyme treatment stevia, l-menthol, raspberry flavor, sorbitol, purified water

  • Package Label

    60g NDC: 80925-201-01 Label

  • INGREDIENTS AND APPEARANCE
    HONEST-PASTE KIDS 
    dental type silica paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80925-201
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ROSEMARY (UNII: IJ67X351P9)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80925-201-0160 g in 1 TUBE; Type 0: Not a Combination Product10/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/28/2020
    Labeler - BOONCO Co., Ltd (694871408)
    Registrant - BOONCO Co., Ltd (694871408)
    Establishment
    NameAddressID/FEIBusiness Operations
    BOONCO Co., Ltd694871408manufacture(80925-201)
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