Label: PERIOE LUCKY FRESH - BREATH CARE- sodium monofluorophosphate, calcium glycerophosphate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 53208-449-01, 53208-449-02 - Packager: LG Household and Healthcare, Inc.
- 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 28, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS AND PRECAUTIONS
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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
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INGREDIENTS AND APPEARANCE
PERIOE LUCKY FRESH - BREATH CARE
sodium monofluorophosphate, calcium glycerophosphate pasteProduct 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