Label: PERIOE MICROBIOME TOTAL CARE STRONG MINT- sodium fluoride paste, dentifrice

  • NDC Code(s): 43136-820-01
  • Packager: Tai Guk Pharm. Co., Ltd.
  • 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 April 1, 2022

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  • Drug Facts

    Drug Facts

  • Active Ingredient

    Sodium fluoride 0.243% (0.14% w/v fluoride ion)

  • Purpose

    Anticavity toopaste

  • Use

    helps protect against cavities

  • Warnings

    Warnings

    Keep out of reach of children.

    Keep out of reach of children under 6 years of age. Do not swallow. If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away. If an allergic reaction develops, discontinue use immediately.

  • Directions

    Adults and children 2 years of age and and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist. Do not swallow. To minimize swallowing use a pea-sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 years: ask a dentist.

  • Inactive Ingredients

    WATER, SORBITOL, HYDRATED SILICA, SODIUM LAURYL SULFATE, GLYCERIN, FLAVOR, CELLULOSE GUM, TETRASODIUM PYROPHOSPHATE, XANTHAN GUM, TITANIUM DIOXIDE, SORBITAN OLEATE, SODIUM SACCHARIN, CHARCOAL POWDER, BIFIDA FERMENT EXTRACT FILTRATE, SODIUM CHLORIDE, CANNABIS SATINA SEED OIL, PROPOLIS EXTRACT, TOCOPHERYL ACETATE, XYLITOL

  • Questions?

    1-800-FOR-AVON

  • Principal Display Panel - 153 g Tube Carton

    PERIOE
    MICROBIOME
    TOOTHPASTE

    THE POWER OF PREBIOTICS
    helps support good bacteria
    to maintain healthy balance

    TOTAL CARE

    - CAVITIES - WHITENING - PLAQUE
    - TARTAR - ORAL HYGIENE
    - FRESH BREATH

    STRONG MINT

    153 g net wt. 5.4 oz

    LABEL_CASE_PERIOE MICROBIOME TOTAL CARE TOOTHPASTE 153g

    LABEL_CASE_PERIOE MICROBIOME TOTAL CARE TOOTHPASTE 153g

  • INGREDIENTS AND APPEARANCE
    PERIOE MICROBIOME TOTAL CARE  STRONG MINT
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43136-820
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MICA (UNII: V8A1AW0880)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Strong) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43136-820-011 in 1 CARTON04/01/2022
    1153 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/01/2022
    Labeler - Tai Guk Pharm. Co., Ltd. (689060246)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tai Guk Pharma. Co., Ltd.689060246manufacture(43136-820)
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