Label: CHARM-TEX FLUORIDE- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 77573-011-01, 77573-011-02, 77573-011-03, 77573-011-04, view more
    77573-011-05, 77573-011-06
  • Packager: Jiangsu Aimeili Cosmetic Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 5, 2024

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  • Active ingredients

    Sodium Monofluorophosphate 0.76%(0.1 w/v Fluoride ion)

    Purpose

    Anticavity

  • Uses

    Help protect against cavities.

  • Warnings

    Keep out of the 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 immediately.

    Keep out of reach of children.

  • Directions

    • Adults and children 6 years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.
    • Children 2 to 6 years: Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowing
    • Children under 2 years: Ask a dentist or physician
  • INACTIVE INGREDIENT

    Sorbitol, Silica, Calcium Carbonate, Methylparaben Sodium, Propylparaben Sodium, Flavor, Sodium Saccharin, Water,  SCMC, Sodium Lauryl Sulfate

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CHARM-TEX FLUORIDE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77573-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77573-011-01720 in 1 PACKAGE07/11/2022
    117 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:77573-011-02720 in 1 PACKAGE07/11/2022
    224 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:77573-011-03144 in 1 PACKAGE07/11/2022
    343 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:77573-011-04144 in 1 PACKAGE07/11/2022
    478 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:77573-011-0560 in 1 PACKAGE07/11/2022
    5130 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:77573-011-0660 in 1 PACKAGE07/11/2022
    6181 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02107/10/2022
    Labeler - Jiangsu Aimeili Cosmetic Co.,Ltd. (543903077)
    Registrant - Jiangsu Aimeili Cosmetic Co.,Ltd. (543903077)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Aimeili Cosmetic Co.,Ltd.543903077manufacture(77573-011)
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