Label: PERIOE POP SENSITIVITY CARE PREBIOTIC CLEAN MINT- stannous fluoride paste, dentifrice

  • NDC Code(s): 43136-601-01
  • Packager: Tai Guk Pharm. Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

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 February 17, 2023

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  • Drug Facts

    Drug Facts

  • Active Ingredient

    STANNOUS FLUORIDE 0.454% (0.14% w/v fluoride ion)

  • Purposes

    Anticavity, antigingivitis, antisensitivity toothpaste

  • Uses

    • aids in the prevention of cavities
    • helps prevent gingivitis
    • helps interfere with the harmful effects of plaque associated with gingivitis
    • helps control plaque bacteria that contribute to the develpment of gingivitis
    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • Warnings

    Warnings

    When using this product

    When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist.

    Stop use and ask a dentist

    Stop use and ask a dentist if the sensitivity problem persits or worsens. Sensitive teeth may indicate a serious problem that may need prompt care.

    ​Keep out of reach of children

    Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years & older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
    • do not swallow
    • children under 12 years: ask a dentist.

  • Other information

    • products containing stannous fluoride may produce surface staining of the teeth
    • adequate brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
    • this toothpaste is specially formulated to help prevent staining
    • see your dentist regularly
  • Inactive Ingredients

    WATER, SORBITOL, HYDRATED SILICA, SODIUM LAURYL SULFATE, SODIUM GLUCONATE, FLAVOR, CARRAGEENAN, XANTHAN GUM, ZINC CITRATE, STANNOUS CHLORIDE, SODIUM HYDROXIDE, SODIUM SACCHARIN, SUCRALOSE, TITANIUM DIOXIDE, XYLITOL, SODIUM CHLORIDE, CHARCOAL POWDER, BIFIDA FERMENT EXTRACT FILTRATE

  • Questions?

    1-800-367-2866

  • Distributed by

    DISTR. LG H&H CO., LTD.
    58, SAEMUNAN-RO, JONGNO-GU, SEOUL, KOREA
    www.lghnh.com
    LG H&H
    MADE IN KOREA

  • Principal Display Panel - 120 g Tube Carton

    PERIOE

    POP

    SENSITIVITY
    CARE

    PREBIOTIC
    TOOTHPASTE

    CLEAN MINT
    WITH FLUORIDE

    120g net wt. 4.2 oz.

    Perioe pop sensitivity care prebiotic toothpaste

  • INGREDIENTS AND APPEARANCE
    PERIOE POP SENSITIVITY CARE PREBIOTIC  CLEAN MINT
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43136-601
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STANNOUS CHLORIDE (UNII: 1BQV3749L5)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Clean) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43136-601-011 in 1 CARTON02/17/2023
    1120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/17/2023
    Labeler - Tai Guk Pharm. Co., Ltd. (689060246)
    Registrant - LG H&H Co., Ltd. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tai Guk Pharma. Co., Ltd.689060246manufacture(43136-601)
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