ANTICAVITY- sodium fluoride mouthwash 
H-E-B

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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HEB-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

store at room temperature (59º-77ºF)

Disclaimer

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

other information

Contains proxide which releases oxgen while whitening.  This may cause the bottle to inflate sligtly or release air when opened

Adverse reactions section

MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TX 78204

4

principal display panel

Compare to Listerine Healthy White

Vibrant Anticavity Mouthrinse

H-E-B

Fresh Mint

GLEAMING

WHITE

ANTICAVITY MOUTHRINSE

SODIUM FLUORIDE AND ACIDULATED

PHOSPHATE TOPICAL SOLUTION

IMPORTANT: read directions for proper use.

32 FL OZ (946 mL)

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-435
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:37808-435-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/21/2015
Labeler - H-E-B (007924756)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(37808-435)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(37808-435)

Revised: 4/2022
Document Id: 966c27b8-fb86-4a2e-a31f-825b27b539b1
Set id: d0a52519-3339-40ea-93e5-78f76d348a4d
Version: 13
Effective Time: 20220420
 
H-E-B