Anticavity Fluoride Rinse

Manufacturer
Fred's Inc | Vi Jon, LLC
Effective date
2022-12-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:45:13

Label at a glance#

ProductAnticavity Fluoride Rinse
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

WARNINGS SECTION

Warnings

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

  • store at controlled room temperature 20⁰ -25 ⁰ C (68 ⁰ - 77 ⁰ F)
  • cold weather may temporarily cloud this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

*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

PACKAGE LABEL.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 descriptionimage description

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TK1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022Y1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NN1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M21
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6F1
SORBITOLINACTIVE INGREDIENT506T60A25R1
sucraloseINACTIVE INGREDIENT96K6UQ3ZD41
THYMOLINACTIVE INGREDIENT3J50XA376E1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55315-16355315-163-86

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 364 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2POWDER, FOR SUSPENSION / ORAL0.01 mgExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR139.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SUSPENSION / INTRATYMPANIC63 mgExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1751 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / SUBCUTANEOUS0.11 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / ORAL140 mgExact identifier — unii candidate
48 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPASTE, DENTIFRICE / DENTAL1.1 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, DELAYED RELEASE / ORAL199 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FLIQUID / INTRAVENOUS381 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRALESIONAL28 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION/ DROPS / OPHTHALMIC1.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
42 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET, ORALLY DISINTEGRATING / ORAL14 mgExact identifier — unii candidate
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, SOLUTION / INTRAVENOUS4050 mgExact identifier — unii candidate
44 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
8 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCREAM / TOPICAL0.36 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii candidate
44 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSPRAY / NASAL49 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION/ DROPS / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRA-ARTICULAR36 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDDOUCHE / VAGINALNAExact identifier — unii candidate
37 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASUSPENSION / ORAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / SUBLINGUALNAExact identifier — unii candidate
28 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SPRAY, METERED / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE, DELAYED RELEASE / ORAL43 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / DENTAL1.47 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii candidate
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
22 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNLOTION / TOPICAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRA-ARTICULAR28 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FAEROSOL, FOAM / TOPICAL0.09 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YTABLET / ORAL10 mgExact identifier — unii candidate
8 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
95f7c7f5-72ea-4e48-8f38-ef9e8d301165ffc0804a-3f3b-428d-bb1b-3981990efdd12023-10-09WarningsExact identifier
spl set id: ffc0804a-3f3b-428d-bb1b-3981990efdd1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.