ANTICAVITY- sodium fluoride mouthwash 
Dolgencorp, LLC

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Anticavity Fluoride Rinse
163.005/163AF-AG

Tamper Evident Statement

SEALED WITH PRINTED NACKBAND FOR YOUR PROTECTION

Active ingredient

Sodium fluoride 0.02% w/v (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:

Other information

Inactive ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Adverse Reaction

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

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed!

If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied.

(888)309-9030

DSP-TN-21091

DSP-MO-20087DSP-MO-28

SDS-MO-20068

Principal Panel Display

Since 1903

Rexall

Anticavity

Fluoride

Mouthwash

Sodium Fluoride and Acidulated Phosphate Topical Solution

IMPORTANT: read directions for proper use.

1 L (1 QT 1.8 FL OZ) 33.8 FL OZ

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-163
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
THYMOL (UNII: 3J50XA376E)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-163-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02105/13/2006
Labeler - Dolgencorp, LLC (068331990)
Registrant - Vi-Jon, LLC (088520668)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55910-163)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55910-163)

Revised: 10/2023
Document Id: 128f7842-7a44-4605-9a0d-10da8a9b3660
Set id: 64f3d92d-f58c-4bc2-8819-f91492221ddb
Version: 14
Effective Time: 20231009
 
Dolgencorp, LLC