PERIOE LUCKY FRESH - CAVITY CARE - sodium monofluorophosphate, pyridoxine hydrochloride, calcium glycerophosphate paste 
LG Household and Healthcare, Inc.

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.

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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 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

Revised: 4/2010
Document Id: 953a9f75-39fb-4fa2-8ca0-81324ebbbfb9
Set id: abdd24ae-3dee-4a47-8c43-0bdeaf04e7f4
Version: 1
Effective Time: 20100421
 
LG Household and Healthcare, Inc.