Label: PERIOE WHITENING ESSENTIALS FRESH ALOE GREEN MINT- sodium fluoride paste, dentifrice

  • NDC Code(s): 43136-802-01
  • 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 March 31, 2020

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  • Drug Facts

    Drug Facts

  • Active Ingredient

    Sodium fluoride 0.243% (0.16% w/v fluoride ion)

  • Purpose

    Anticavity

  • 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 more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 6 years and olderBrush teeth thoroughly after each means or at least twice a day, or as directed by a dentist and physician. Do not swallow.
    Children between 6 and 12 yearsTo minimize swallowing, use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
    Children under 6 yearsAsk a dentist or physician.

  • 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, citru limon(lemon) fruit extract, sodium chloride, aloe extract

  • QUESTIONS

    1-800-FOR-AVON

    www.avon.com

  • Principal Display Panel - 156 g Tube Carton

    PERIOE

    Whitening Essentials. ALOE

    FLUORIDE TOOTHPASTE

    CAVITY PROTECTION

    HELPS WHITEN TEETH - REMOVES SURFACE STAINS

    FRESH ALOE

    GREEN MINT

    NET WT 5.5 oz (156 g)

    PERIOE Whitening Essentials Fresh Aloe Green Mint 156g

  • INGREDIENTS AND APPEARANCE
    PERIOE WHITENING ESSENTIALS  FRESH ALOE GREEN MINT
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43136-802
    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
    HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MICA (UNII: V8A1AW0880)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALOE (UNII: V5VD430YW9)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINT (Fresh Aloe) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43136-802-011 in 1 CARTON03/31/2020
    1156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/31/2020
    Labeler - Tai Guk Pharm. Co., Ltd. (689060246)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tai Guk Pharma. Co., Ltd.689060246manufacture(43136-802)
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