ANTICAVITY- sodium fluoride mouthwash 
Libertu Procurement, Inc

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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Anticavity Rinse
435.000-435AA

Active Ingredient

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

for this product

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:

Inactive ingredients

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

Other information

Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate slightly or release air when opened.

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

To open:  remove tamper evident neckband.  Squeeze both tabs at base of cap while turning the cap until loose.  To close: Place cap back on bottle and turn cap until it clicks twice and feels secure

Distributed by

Liberty Procurement Co. Inc.

Union, NJ 07083 USA

www.facevalues.com

SATISFACTION GUARANTEED

Or Your Money Back

principal display panel

CORE VALUES

Compare to Listerine Healty White Vibrant

Advanced WHITENING ANTICAVITY MOUTHRINSE

5 DAYS to Whiter Teeth

Fresh Mint

IMPORTANT: Read directions for proper use.

946 mL (32 FL OZ)

Sealed With Printed Neckband For Your Protection

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-435
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:63940-435-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/15/2015
Labeler - Libertu Procurement, Inc (804085293)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(63940-435)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(63940-435)

Revised: 9/2023
Document Id: 259f34a8-c237-4a02-9b7a-6dd0d8a63732
Set id: e838aa91-205c-4722-839a-935850c8af6b
Version: 21
Effective Time: 20230927
 
Libertu Procurement, Inc