Label: PERIOE POP ADVANCED WHITENING PREBIOTIC COOL MINT- sodium fluoride paste, dentifrice

  • NDC Code(s): 43136-602-01
  • 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 February 17, 2023

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  • Drug Facts

    Drug Facts

  • Active Ingredient

    SODIUM FLUORIDE 0.243% (0.16% w/v fluoride ion)

  • Purpose

    Anticavity toothpaste

  • 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 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

    GLYCERIN, HYDRATED SILICA, SODIUM HEXAMETAPHOSPHATE, WATER, PEG-6, FLAVOR, TRISODIUM PHOSPHATE, SODIUM LAURYL SULFATE, CARRAGEENAN, COCAMIDOPROPYL BETAINE, SODIUM SACCHARIN, SUCRALOSE, XANTHAN GUM, TITANIUM DIOXIDE, MICA, CHARCOAL POWDER, SODIUM CHLORIDE, CITRUS LIMON (LEMON) FRUIT ETRACT, XYLITOL, 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

    ADVANCED
    WHITENING

    PREBIOTIC
    TOOTHPASTE

    COOL MINT
    WITH FLUORIDE

    120g net wt. 4.2 oz.

    Perioe pop advanced whitening prebiotic toothpaste

  • INGREDIENTS AND APPEARANCE
    PERIOE POP ADVANCED WHITENING PREBIOTIC  COOL MINT
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43136-602
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LEMON (UNII: 24RS0A988O)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Cool) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43136-602-011 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(43136-602)
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