RITE AID PRO DEFENSE  WHITENING- stannous fluoride paste, dentifrice 
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 Pro Defense Whitening Toothpaste

Drug Facts

Active ingredient

Stannous fluoride 0.454% (w/w)

Purpose

Anticavity / Anti-gingivitis

Uses

Warnings

Stop use and ask a dentist if:

  • gingivitis, bleeding or redness persists for more than 2 weeks
  • if you have painful or swollen gums, pus from the gum line, loose teeth or increasing space between teeth. These may be symptoms of periodontis, a serious form of gum disease.

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day or as day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing

Other information

Inactive ingredients Glycerin, Water, Hydrated Silica, Pentasodium Triphosphate, Cellulose Gum, Cocamidopropyl Betaine, Titanium Dioxide, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin

DISTRIBUTED BY:

RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

RITE AID® PHARMACY

oral care

pro defense

daily fluoride anticavity & anti-gingivitis toothpaste

whitening

NET WT 3.4 OZ (96.4 g)

RA PRO DEFENSE 2821284R1

RITE AID PRO DEFENSE   WHITENING
stannous fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6034
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.454 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-6034-91 in 1 CARTON03/03/2019
196.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/03/2019
Labeler - Rite Aid (014578892)
Registrant - Lornamead Inc. (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.080046418manufacture(11822-6034)

Revised: 1/2023
Document Id: f2009f11-925b-2e6a-e053-2995a90ab63d
Set id: 83374382-5ea7-79c8-e053-2991aa0a4e1d
Version: 10
Effective Time: 20230111
 
Rite Aid