PERIOE LUCKY FRESH - BREATH CARE - sodium monofluorophosphate, 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%

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 - BREATH CARE 
sodium monofluorophosphate, calcium glycerophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-449
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium Glycerophosphate (UNII: XWV9Z12C1C) (Calcium Glycerophosphate - UNII:XWV9Z12C1C) Calcium Glycerophosphate.13 g  in 100 g
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium Monofluorophosphate.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Calcium Carbonate (UNII: H0G9379FGK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Sorbitol (UNII: 506T60A25R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Methylparaben (UNII: A2I8C7HI9T)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Sorbitan Monooleate (UNII: 06XEA2VD56)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
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:53208-449-021 in 1 CARTON
1NDC:53208-449-01130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35504/28/2010
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: d6f74226-da81-4754-9664-c2375b8cda1f
Set id: 89ad8b9b-5ebf-4f12-b4b2-c68c3a342125
Version: 1
Effective Time: 20100428
 
LG Household and Healthcare, Inc.