FDA.reportPublic FDA data

MINT'EVO 971.001/971AB

Manufacturer
Rockland Cosmetics, Inc. | Nice-Pak Products, LLC
Effective date
2026-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:58:11

Label at a glance#

Productsodium fluoride rinse
Active ingredientSODIUM FLUORIDE
Label structure13 sections

Dosage and administration

Adults and children 6 years of age and older: use twice daily after brushing your teeth with a toothpaste vigorously swish 10 mL 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 instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supe...

Label contents#

Full prescribing information#

Tamper Evident Statement

SPL UNCLASSIFIED SECTION

Sealed with printed neckband for your protection.

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warning

WARNINGS SECTION

for this product.

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 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL 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
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

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

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Questions or comments?

OTC - QUESTIONS SECTION

Call 877-757-5005

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ® Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

Adverse Reactions

ADVERSE REACTIONS SECTION

Distributed by: Rockland Cosmetics, Inc.

Hillburn, NY 10931

www.RocklandCosmetics.com

Made in the U.S.A. with U.S. and foreign components.

NSK

New Square Kashrus

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO LISTERINE ® ZERO ALCOHOL*

mint'evo

EVOLUTIONIZING ORAL FRESHNESS

FLUORIDE ANTI-CAVITY MOUTHWASH

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

ALCOHOL FREE

HELPS STRENGTHEN TEETH TO FIGHT CAVITIES

FRESHENS BREATH

FRESH MINT

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

1 L (1.05 QT) 33.8 FL OZ

mm01mm01mm02mm02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN1
313029sodium fluoride 0.2 MG/ML MouthwashSCD1
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY1
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69892-971-86sodium fluoride rinse1000 mL in 1 BOTTLE, PLASTICLIQUID10001

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69892-97169892-971-86

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
EUCALYPTOLRV6J6604TKIACT
SPEARMINT OILC3M81465G5IACT
PHOSPHORIC ACIDE4GA8884NNIACT
METHYL SALICYLATELAV5U5022YIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
DISODIUM PHOSPHATE22ADO53M6FIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM LAURYL SULFATE368GB5141JIACT
THYMOL3J50XA376EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLOXAMER 407TUF2IVW3M2IACT
SORBITOL506T60A25RIACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
SODIUM BENZOATEOJ245FE5EUIACT

Source Document#

Source XML

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
sodium fluoride rinseSODIUM FLUORIDE RINSERockland Cosmetics, Inc.52430b12-4d5f-d1e1-e063-6394a90abd642026-05-20Warnings, Adverse reactionsExact identifier
ndc (package): 69892-971-86
ndc (product): 69892-971
ndc11 (package): 69892097186
spl id: 52430b12-4d60-d1e1-e063-6394a90abd64
spl set id: 52430b12-4d5f-d1e1-e063-6394a90abd64

Reported adverse events (FAERS/openFDA)#

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