ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash 
Fred's Inc

----------

Anticavity Fluoride Mouthwash
163.005/163AF-AG  

Active ingredient

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 12 years of age and older:

  • use twice daily after brushing your teeth with 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
  • supervise children as necessary until capable of using without supervision
  • children under 12 years of age: consult a dentist or doctor

Other information

  • store at controlled room temperature 20⁰ -25⁰ C (68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product

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

*This product is not manufacturd or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Anticavity Mouthwash

DISTRIBUTED BY: Fred's Inc.
4300 NEW GETTWELL, RD MEMHIS, TN 38118
Fred's promise
Not Happy with This Product?
Just Bring It Back For a Refund!

principal display panel

Sealed With Printed Neckband For Your Protecion

Fred's

IMPOTANT: Read directions for proper use.

Anticavity Fluoride Mouthwash

Eucalyptus Mint

Sodium Fluoride and Acidulated Phosphate Topical Solution

Helps Prevent Cavities

Restores Enamel

Helps Strengthen Teeth

Helps Kills Germs That Cause Bad Breath

Freshens Breath

Fred's LAB TESTED

Lab Tested for Quality, Fred Tested for Satisfaction

Compare to the Active Ingredient of Listerine Total Care

1L (33.8 FL OZ)

image description

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-163
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 (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:55315-163-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/201203/07/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02106/28/201203/07/2021
Labeler - Fred's Inc (005866116)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(55315-163)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(55315-163)

Revised: 10/2023
 
Fred's Inc