SODIUM FLUORIDE- sodium fluoride solution 
Target Corp.

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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Whitening Anticavity Mouth Rinse

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

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 6 years of age and older:

children under 6 years of age: consult a dentist or doctor

Inactive ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Other information

store at room temperature (59º-77ºF)

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine HealthyWhite Anticavity Mouthrinse

Principal Display Panel

SAFETY SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

IMPORTANT: read directions for proper use

Whitening

Anticavity mouth rinse

Begins working on contact

5 days to whiter teeth

Helps strengthen teeth

Kills germs that cause bad breath

Fresh mint flavor

32 fl oz (946 mL)

mm01

SODIUM FLUORIDE 
sodium fluoride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-435
Route of Administrationoral
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MENTHOL (UNII: L7T10EIP3A)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11673-435-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/28/2015
Labeler - Target Corp. (006961700)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, Inc.790752542manufacture(11673-435) , analysis(11673-435)

Revised: 7/2015
Document Id: 9c1e85c3-3243-4bbe-9e11-70d4f18978eb
Set id: 4ad0ad31-d2ba-45b5-82e2-b4123e466f18
Version: 2
Effective Time: 20150701
 
Target Corp.