PERIOE LUCKY FRESH - BREATH CARE- sodium monofluorophosphate, calcium glycerophosphate paste

Perioe lucky fresh - breath care by

Drug Labeling and Warnings

Perioe lucky fresh - breath care by is a Otc medication manufactured, distributed, or labeled by LG Household and Healthcare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Monofluorophosphate 0.76%

Calcium Glycerophosphate 0.13%

PURPOSE

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

WARNINGS AND PRECAUTIONS

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.

DOSAGE & ADMINISTRATION

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

INGREDIENTS AND APPEARANCE

PERIOE LUCKY FRESH - BREATH CARE 
sodium monofluorophosphate, calcium glycerophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53208-449
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-449-02	1 in 1 CARTON
1	NDC: 53208-449-01	130 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part355	04/28/2010

Labeler - LG Household and Healthcare, Inc. (688276187)

Registrant - LG Household and Healthcare, Inc. (688276187)

Establishment
Name	Address	ID/FEI	Business Operations
LG Household and Healthcare, Inc.		688276187	manufacture