ANTICAVITY- sodium fluoride rinse 
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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Anticavity Fluoride Rinse, Bubble Gum  
004.002/004AE

Active ingredient

Sodium fluoride 0.05% (0.02% 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, see professional assistance or contact a Poison Control Center immediately.

Directions

Adults and children 6 years of age and older:

Children under 6 years of age: consult a dentist or doctor

Other information

Inactive ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Adverse Reaction

Sealed with printed neckband for your protection

Visit us at: Rexall.com or call 1-866-4-REXALL

DISTRIBUTED BY Old East Main CO,

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.

Principal display panel

DG health

Compare to Act Bubblegum Blowout

Anticavity Kids Fluoride Rinse

KIDS

Anticavity Fluoride Rinse

Strong Cavity Protection

Helps Strengthen Teeth

Alcohol Free

IMPORTANT: Read directions for proper use

Bubblegum Flavor

16.9 FL OZ

(500 mL)

image description

Principal display panel

Since 1903

Rexall

kids

Anticavity

Fluoride Rinse

Anticavitvy Fluoride Rinse

IMPORTANT: read directions for proper use.

ADA Accepted

America Dental Association

Helps Prevent cavities

Bubblegum Flavor

500 mL (1 PT 0.9 FL OZ) 16.9 FL OZ

image description

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-030
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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-030-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2015
2NDC:55910-030-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/24/2015
Labeler - Old East Main Co (068331990)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55910-030)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55910-030)

Revised: 9/2023
Document Id: 9af580f8-30cd-4934-b376-abea5e1a1c03
Set id: f8036e2e-7541-4922-92b9-0d8319f7b64c
Version: 24
Effective Time: 20230907
 
Old East Main Co