ANTICAVITY- sodium fluoride mouthwash 
Old East Main 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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Dollar General 435

Active Ingredient

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

Purpose

Anticavity

Use

aid in the preventon 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:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • 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 Healthy Vibrant Anticavity Mouthrinse

TEP

Sealed With Printed Neckband For Your Protection

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

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Ultraclean With Everfresh Technology - Fresh Citrus

DISTRIBUTED BY

Old East Main CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

principal display panel

DG Health

Compare to

Listerine HealthyWhite

Anticavity Mouthrinse

GLOWING

WHITE

Anticavity Mouthrinse

FRESH MINT

5 DAYS TO WHITER TEETH

Begins working on contact

Helps strengthen teeth

Kills germs that cause bad breath

IMPORTANT: read directions for proper use

16 FL OZ (474 mL)

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-941
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:55910-941-43474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/201504/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/21/201504/14/2022
Labeler - Old East Main CO. (068331990)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55910-941)

Revised: 4/2022
 
Old East Main CO.