Label: CHARM TEX FLUORIDE- sodium fluoride paste

  • 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 October 14, 2019

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  • Active Ingredient

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

  • Purpose

    Anticavity

  • 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 immediately.

  • 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:Use only a pea sized amount and supervise child’s brushing and rinsing to minimize swallowing.
    Children under 2:Ask dentist or physician

  • Inactive Ingredients

    Sorbitol, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Saccharin, Flavour, Treated Water, SCMC,
    Sodium Lauryl Sulfate

  • 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
    CHARM TEX FLUORIDE 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73343-003
    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
    SORBITOL (UNII: 506T60A25R)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73343-003-0178 g in 1 TUBE; Type 0: Not a Combination Product10/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/15/2019
    Labeler - Yangzhou Tracey Daily Chemical Plastic Co., Ltd. (560398069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou Tracey Daily Chemical Plastic Co., Ltd.560398069manufacture(73343-003)
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