ANTICAVITY- sodium fluoride mouthwash 
DZA Brands, LLC

----------

Anticavity Fluoride Mouth Rinse 
163.005/163AF-AG

Active ingredent

Sodium fluoride 0.0221% (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:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 yeard of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without up supervision
  • children under 6 years of age: consult a dentist or doctor

Other information

  • store at controlled room temperature 20°-25° C to (68° - 77°F)
  • cold weather may temporarily cloud this product

Inactive ingredients

water, alcohol (21.6%), sorbitol, poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disodium posphate red 40, blue 1

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, Distributor of Listerine Total Care Fresh Mint Anticavity Mouthwash

DISTRIBUTED BY: DZA BRANDS, LLC
2110 EXECUTIVE DRIVE
Salisbury, NC 28147
For product questions or concerns, contact us at 1-866-322-2439. Please include UPC number and code from package

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

healthy accents

eucalyptus mint anticavity fluoride mouth rinse

IMPORTANT: Read directions for proper use.

compare to the ingredients of Listerine Total Care Fresh Mint Anticavity Mouthwash*

1 L (33.8 FL OZ)

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-003
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)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
THYMOL (UNII: 3J50XA376E)  
PHOSPHORAMIDIC ACID (UNII: 9Q189608GB)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MENTHOL (UNII: L7T10EIP3A)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-003-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/200607/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02105/13/200607/31/2020
Labeler - DZA Brands, LLC (090322194)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(55316-003)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(55316-003)

Revised: 10/2023
Document Id: a3cc12dc-0bb8-4119-8967-a407ce94871d
Set id: 7f897e3b-e720-429e-9314-eef78c570d75
Version: 12
Effective Time: 20231009
 
DZA Brands, LLC