RITE AID ANTI-CAVITY, ANTI-GINGIVITIS  - stannous fluoride paste 
Rite Aid

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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Rite Aid Protec-Health Anti-Cavity, Anti-Gingivitis Toothpaste

Active Ingredient

STANNOUS FLUORIDE 0.454%................ANTICAVITY, ANTIGINGIVITIS
(.016% WITH FLUORIDE ION)                   antisensitivity toothpaste



USE

Helps aid in the prevention of cavities.

When using this product do not use for sensitivity

longer than four weeks unless recommended by dentist.

Stop use and ask a dentist if the sensitivity problem persists or

worsens.  Sensitive teeth may indicate a serious problem.

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:

Sorbitol, Water, Hydrated Silica, Sodium Hexametaphosphate, Glycerin, Sodium Lauryl Sulfate, Zinc Lactate, PEG-6, Cellulose Gum, Sodium Phosphate, Sodium Gluconate, Saccharin Sodium, Titanium Dioxide, Blue 1, Yellow 4

image of container

RITE AID ANTI-CAVITY, ANTI-GINGIVITIS  
stannous fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O) Stannous Fluoride4.54 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorMINT (Clean Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0001-1170 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/08/2010
Labeler - Rite Aid (014578892)

Revised: 12/2010
Document Id: 5b1b8e3e-02ed-4c80-ba69-4a6f72b1a27f
Set id: 64ef6ae7-babe-44bf-9991-8a9f1c1a83bf
Version: 6
Effective Time: 20101208
 
Rite Aid