Label: PERIOE LUCKY FRESH - CAVITY CARE- sodium monofluorophosphate, pyridoxine hydrochloride, calcium glycerophosphate paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 21, 2010

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  • ACTIVE INGREDIENT

    Sodium Monofluorophosphate 0.76%
    Pyridoxine Hydrochloride 0.03%
    Calcium Glycerophosphate 0.13%

    Aids in the prevention of : Cavity, Plaque, Bad Breath

    As with all fluoride toothpastes, keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

    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. Do not swallow.

    Children under 6 years of age: To minimize swallowing, use a peasized  amount and supervise brushing until good habits are established.

    Children under 2 years: Ask a dentist or physician.
  • PRINCIPAL DISPLAY PANEL

    PERIO Lucky Fresh

    Herbal Mint Breath Care

    Refreshing Herbal Breeze




    Perioe Lucky Fresh Herbal Mint Breath Cavity Care Eng

    cavitycarekor





  • INGREDIENTS AND APPEARANCE
    PERIOE LUCKY FRESH - CAVITY CARE 
    sodium monofluorophosphate, pyridoxine hydrochloride, calcium glycerophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-448
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) Sodium Monofluorophosphate0.76 g  in 100 g
    Pyridoxine hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine hydrochloride0.03 g  in 100 g
    Calcium Glycerophosphate (UNII: XWV9Z12C1C) (Calcium Glycerophosphate - UNII:XWV9Z12C1C) Calcium Glycerophosphate0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Calcium Carbonate (UNII: H0G9379FGK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Sorbitol (UNII: 506T60A25R)  
    Xylitol (UNII: VCQ006KQ1E)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Sorbitan Monooleate (UNII: 06XEA2VD56)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-448-021 in 1 CARTON
    1NDC:53208-448-01130 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35504/26/2010
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Registrant - LG Household and Healthcare, Inc. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Healthcare, Inc.688276187manufacture
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