ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash 
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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Drug Facts

Active ingredient

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warning

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

Directions

Adults and children 12 years of age and older:

Other information

Inactive ingredients

water, alcohol (21.6%), sorbitol, poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disosium phosphate, red 40, blue 1

*This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash

DISTRIBUTED BY:

RITE AID

3O Hunter Lane, Camp Hill, PA 17011

DSP-TN-1500

DSP-MO-34

SDS-TN-15012

Principal Display Panel

RITE AID PHARMACY

Sealed With Printed Neckband For Your Protection

IMPORTANT: READ DIRECTIONS FOR PROPER USE

*Compare to the active ingredient in Listerine Total Care Anticavity Mouthwash

Anticavity Mouthwash

Sodium Fluoride and Acidulated Phosphate Topical Solution

fresh mint

helps prevent cavities

restores enamel

helps strengthen teeth

helps kill bad breath germs

leaves the mouth feeling clean

1 LITER ( 33.8 FL OZ)

image description

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3705
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
THYMOL (UNII: 3J50XA376E)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
sucralose (UNII: 96K6UQ3ZD4)  
MENTHOL (UNII: L7T10EIP3A)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-3705-41000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/04/1994
Labeler - Rite Aid (014578892)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon790752542manufacture(11822-3705)

Revised: 2/2016
Document Id: 1c20cdd2-4e79-4edb-8137-36e7f7d5ee23
Set id: e842972e-3041-47f1-b795-64edba3f58e9
Version: 2
Effective Time: 20160226
 
Rite Aid