Perioe lucky fresh - cavity care

Dosage form: paste
Ingredients: Sodium Monofluorophosphate 0.76g in 100g, Pyridoxine hydrochloride 0.03g in 100g, Calcium Glycerophosphate 0.13g in 100g
Labeler: LG Household and Healthcare, Inc.
NDC Code: 53208-448

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 Facts

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.

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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 AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (FLUORIDE ION) Sodium Monofluorophosphate0.76 g  in 100 g
Pyridoxine hydrochloride (Pyridoxine) Pyridoxine hydrochloride0.03 g  in 100 g
Calcium Glycerophosphate (Calcium Glycerophosphate) Calcium Glycerophosphate0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Calcium Carbonate 
SILICON DIOXIDE 
Sorbitol 
Xylitol 
CARBOXYMETHYLCELLULOSE SODIUM 
Xanthan Gum 
SACCHARIN SODIUM 
Methylparaben 
Sodium Lauryl Sulfate 
Sorbitan Monooleate 
FD&C BLUE NO. 1 
D&C YELLOW NO. 10 
Water 
Packaging
#Item CodePackage Description
1NDC:53208-448-021 TUBE (TUBE) 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/FEIOperations
LG Household and Healthcare, Inc.688276187manufacture

Revised: 04/2010
 
LG Household and Healthcare, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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