ANTICAVITY- sodium fluoride mouthwash 
Kroger Co

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 0.02% (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:

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.

*Listerine is a registered trademark of Johnson & Johnson Healthcare Products, New Brunswick, NJ 08903.  Johnson & Johnson Healthcare Products is not affiliated with The Kroger Co. or this product.

DISTRIBUTED BY

The Kroger Co.

Cincinnatti, OH 45202

800-632-6900 www.kroger.com

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Compare to the ingrdients of Listerine Healthy White Vibrant Anticavity Mouthrinse *See back label

Fresh Mint

Whitening Anticavity Mouthrinse

Safely whitens teeth

Kills germs that cause bad breath

Helps strengthen teeth

Sealed with printed neckband for your protection

IMPORTANT: Read directions for proper use

946 mL (32 FL OZ)

PDP

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-435
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:30142-435-45946 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 finalpart35509/15/2015
Labeler - Kroger Co (006999528)
Registrant - Vi-Jon, Inc. (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, Inc.790752542manufacture(30142-435)

Revised: 2/2016
Document Id: 99a6099c-26b0-4f8e-9bcf-2cb836cc4481
Set id: a17d11a1-3a75-4482-bd15-3bc3c489c876
Version: 2
Effective Time: 20160222
 
Kroger Co