KIT 2 (SODIUM FLUORIDE) KIT [BUZZ EXPORT SERVICES PTY., LTD.]

KIT 2 (SODIUM FLUORIDE) KIT [BUZZ EXPORT SERVICES PTY., LTD.]
PDF | XML

NDC 69491-080-00, 69491-081-00
Set ID 4705d0bc-a1a4-26db-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Buzz Export Services Pty., Ltd.
Generic Name
Product Class
Product Number
Application Number PART355
  • Drug Facts

  • Active ingredient

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

    Purpose

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • Warning

    Keep out of reach of children 

    under 6 yrs. of age. if more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least tweice a day or use as directed by a dentist 
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6 
    • children under 2 yrs: ask a dentist
  • Inactive ingredients

    glycerin, hydrated silica, sodium hexametaphosphate, water, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine sodium saccharin, PEG-20M or PEG-23M, Xanthan gum, sucralose, mica, titanium dioxide

  • Questions?

    1-800-492-7378

  • Package Labeling:

    LabelKit

  • INGREDIENTS AND APPEARANCE
    KIT 2 
    sodium fluoride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69491-080
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69491-080-001 in 1 TUBE01/25/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 24 g
    Part 1 of 1
    CREST 3D WHITE BRILLIANC 
    sodium fluoride paste, dentifrice
    Product Information
    Item Code (Source)NDC:69491-081
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE OXIDE 900000 (UNII: 16P9295IIL)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69491-081-0024 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/24/2017
    Labeler - Buzz Export Services Pty., Ltd. (747317902)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.421290194manufacture(69491-080, 69491-081)

Related Drugs