Label: PREMIER VALUE CAVITY PROTECTION MINT- sodium monofluorophosphate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-005-01 - Packager: Premier Value
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 7, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- USE
- WARNINGS
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Directions
Adults and children Brush teeth thoroughly, preferably
2 years and older after each meal, or at least twice a day, or as
directed by your dentist. Do not swallow.Children under To minimize swallowing, use a pea-sized
6 years of age amount and supervise brushing until
good habits are established.Children under 2 years Ask a dentist or physician.
- Principal Display Panel
- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
PREMIER VALUE CAVITY PROTECTION MINT
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-005 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 7.6 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) CALCIUM CARBONATE (UNII: H0G9379FGK) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM PHOSPHATE (UNII: SE337SVY37) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color white Score Shape Size Flavor MINT (Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-005-01 21 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 09/08/2003 Labeler - Premier Value (101668460)