ALCOHOL FREE REFRESHING MINT- sodium fluoride mouthwash 
HEB

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 576.001/576AC-AD

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

claims

H-E-B

Refreshing Mint

ALCOHOL

FREE

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 oler:

Inactive ingredients

water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1

Questions

Call 1-888-593-0593

Claims

This rinse may cause temporary staining to the surface of teeth.  This is not harmful, and adequate brushing may prevent its occurrence.

Adverse Reactions

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

disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Anticavity Fluoride Mouthwash

principal display panel

Compare to Crest

Pro-Health Anticavity

Fluoride MouthWash

H-E-B

Refreshing Mint

ALCOHOL

FREE

ANTICAVITY MOUTH RINSE

WITH FLUORIDE

IMPORTANT: read directions for proper use.

33.8 FL OZ (1 QT) 1L

image description

ALCOHOL FREE REFRESHING MINT 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-576
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION10.41 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-576-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/27/2015
Labeler - HEB (007924756)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(37808-576)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(37808-576)

Revised: 4/2022
Document Id: 5535461d-443f-4b39-851b-82e32130ba17
Set id: cedf7c08-7412-4733-9b67-225b331cec8c
Version: 10
Effective Time: 20220420
 
HEB