Label: DR.PAUHLS TOOTHPAST E VANILLE BLACK TEA FLAVOR- silicon dioxide, pyridoxine hydrochloride paste, dentifrice

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 26, 2018

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  • ACTIVE INGREDIENT

    Active ingredients: SILICA 13.0%, PYRIDOXINE HYDROCHLORIDE 0.05%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    SORBITOL, SODIUM PCA, GLYCERIN, SODIUM LAURYL SULFATE, FLAVOR, CELLULOSE GUM, MENTHOL, XYLITOL, CITRUSGRANDIS (GRAPEFRUIT) SEED EXTRACT, SODIUM SACCHARIN HYDROXYAPATITE, CAMELLIA SINENSIS LEAF EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, PROPOLIS EXTRACT

  • PURPOSE

    Purpose: Anti-plaque, Anti-caries, Anti-periodontitis

  • WARNINGS

    Warnings:

    Keep out of the 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 Center right away.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    Uses:

    - Helps protect against cavities

    - reduce plaque

    - gum health

    - Helps protect against gingivitis, periodontitis

    - Helps freshen breath

    - brightening teeth

  • Directions

    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 physician

    Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

    Children under 2 years: Ask a dentist or physician

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DR.PAUHLS TOOTHPAST E VANILLE BLACK TEA FLAVOR 
    silicon dioxide, pyridoxine hydrochloride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72265-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE13.0 g  in 100 g
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE0.05 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72265-030-021 in 1 CARTON07/01/2018
    1NDC:72265-030-01100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2018
    Labeler - CURESCRIPT (694894509)
    Registrant - CURESCRIPT (694894509)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kumho Dental Pharm. Co., Ltd.631133766manufacture(72265-030)