WHITE-GLO 2IN1 WITH MOUTHWASH (SODIUM MONOFLUOROPHOSPHATE) PASTE [HUAIAN ZONGHENG BIO-TECH CO., LTD]

WHITE-GLO 2IN1 WITH MOUTHWASH (SODIUM MONOFLUOROPHOSPHATE) PASTE [HUAIAN ZONGHENG BIO-TECH CO., LTD]
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NDC 71167-002-01, 71167-002-02
Set ID 4b50f74b-d1d4-2827-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager HUAIAN ZONGHENG BIO-TECH CO., LTD
Generic Name
Product Class
Product Number
Application Number PART355
  • Active Ingredient

    sodium monofluorphosphate  0.76%

  • Purpose

    Anticavitytoothpaste

  • Use

    helps protect against cavities

  • Warning

    Keep out of reach of children under 6 years of age.

    If more than used for brushing is accidently swallowed get medical help or contact a poison control center right away.

  • Directions

    Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist.

    do not swallow

    to minimize swallowing use a pea-sized amount in children under 6

    supervise children's burshing ntil good habits are established

    children under 2 years ask a dentist

  • Inactive Ingredients

    Calcium Carbonate,Aqua,Glycerin,denature alcohol(2.5%),Sorbitol,Silica,Aroma,Sodium Lauryl Sulphate,Carboxymethyl Hydroxyethyl cellulose,Chondrus Crispus,CI77891(Titanium Dioxide),Sodium saccharin,rose canina fruit oil

  • Keep out of reach of children under 6 years of age

    Keep out of reach of children under 6 years of age

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    WHITE-GLO 2IN1 WITH MOUTHWASH 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71167-002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)  
    ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71167-002-0124 in 1 BOX07/10/2016
    1150 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71167-002-0248 in 1 BOX07/10/2016
    2150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/10/2016
    Labeler - HUAIAN ZONGHENG BIO-TECH CO., LTD (527152733)
    Establishment
    NameAddressID/FEIBusiness Operations
    HUAIAN ZONGHENG BIO-TECH CO., LTD527152733manufacture(71167-002)

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