Label: HONEST-PASTE- precipitated calcium carbonate paste

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

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Drug Label Information

Updated January 11, 2022

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  • Active ingredients

    Precipitated calcium carbonate 30%

  • 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

    • adults and children 6 years of age and older apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician.
    • children under 6 years of age: consult a dentist or physician
  • Inactive ingredients

    glycerin, silicon dioxide, cellulose gum, xanthan gum, sodium cocoyl glutamate, xylitol, green tea extract, licorice root extract, calendula extract, chamomile extract, sage extract, grapefruit seed extract, enzyme treatment stevia, myrrh, propolis extract, aloe extract, l-menthol, spearmint oil, peppermint oil, eucalyptus oil, sodium pyrophosphate, purified water

  • Package Label

    120g NDC: 80925-202-01 Label

  • INGREDIENTS AND APPEARANCE
    HONEST-PASTE 
    precipitated calcium carbonate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80925-202
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    MYRRH (UNII: JC71GJ1F3L)  
    SAGE (UNII: 065C5D077J)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CITRUS MAXIMA SEED (UNII: 083X55C543)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80925-202-01120 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(80925-202)
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