Label: RITE AID ANTI-CAVITY, ANTI-GINGIVITIS- stannous fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-0001-1 - Packager: Rite Aid
- 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 December 8, 2010
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 after
12 years and older each meal, or at least twice a day, or as
directed by your dentist. Do not swallow.
Children under 12 Ask a dentist or physician
OTHER INFORMATION Products containing stannous fluoride
may produce surface staining of the teeth. Adequate toothbrushing
may prevent these stains which are not harmful or perment.
- Inactive ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RITE AID ANTI-CAVITY, ANTI-GINGIVITIS
stannous fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O) Stannous Fluoride 4.54 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) ZINC LACTATE (UNII: 2GXR25858Y) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SODIUM PHOSPHATE (UNII: SE337SVY37) SODIUM GLUCONATE (UNII: R6Q3791S76) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color white Score Shape Size Flavor MINT (Clean Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0001-1 170 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/08/2010 Labeler - Rite Aid (014578892)