FDA.reportPublic FDA data

Willo Minty Mist Dye Free

Manufacturer
Willo 32, Inc.
Effective date
2025-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:13:54

Key Label Information#

Active Ingredients And Purpose

Drug Facts

Active ingredient Sodium fluoride 0.22% (0.10% w/v fluoride ion)

Purpose

Purpose Anticavity

Uses

Use

Use Aids in the prevention of dental cavities

Warnings

Warnings

Warnings

Directions And Dosage

Directions

Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor children under 6 years of age instruct in good brushing habits (to minimize swallowing). Supervise as necessary until capable or using without supervision children under 2 years of age consult with a dentist or doctor

Other Label Information

Inactive ingredients

Inactive ingredients Water, Sorbitol, Sodium Cocoyl Glutamate, Glycerin, PEG-400, Sucralose, Flavor, Citric Acid, Beta-Glucan, Sodium Bicarbonate, Sodium Benzoate, Sodium Ascorbyl Phosphate, Stevioside, Menthol, Calcium Citrate

Questions or comments

Questions or comments? Tel: 1(888)509-0459 - Email: support@willo.com Visit us at www.willo.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Willo Minty Mist Anticavity Fluoride Liquid Toothpaste Helps Prevent Cavities & Strengthens Enamel 8 fl oz (237 ml) Scan code to buy another bottle Dist. by: Willo 32, Ince New York, NY 10006 1 (888) 509-0459

Label Images#

Willo_8oz_Minty Mist_DyeFree_Fluoride_DentalBrite_006
Willo_8oz_Minty Mist_DyeFree_Fluoride_DentalBrite_006
Willo_2oz_Box_Minty Mist_DyeFree_Fluoride_DentalBrite_006
Willo_2oz_Box_Minty Mist_DyeFree_Fluoride_DentalBrite_006
Willo_2oz_Minty Mist_DyeFree_Fluoride_DentalBrite_006
Willo_2oz_Minty Mist_DyeFree_Fluoride_DentalBrite_006

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84185-302-02Willo Minty Mist Dye Free59 mL in 1 BOTTLE, PUMPPASTE, DENTIFRICE591
84185-302-08Willo Minty Mist Dye Free237 mL in 1 BOTTLE, DISPENSINGPASTE, DENTIFRICE2371
84185-302-22Willo Minty Mist Dye Free2 in 1 BOXPASTE, DENTIFRICE21

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84185-30284185-302-08, 84185-302-02, 84185-302-22

Ingredients#

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
CALCIUM CITRATEMLM29U2X85IACT
SODIUM BICARBONATE8MDF5V39QOIACT
YEAST .BETA.-D-GLUCAN44FQ49X6UNIACT
PEG-4002AS3MDK9CBIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
STEVIOSIDE0YON5MXJ9PIACT
MENTHOLL7T10EIP3AIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SUCRALOSE96K6UQ3ZD4IACT
CITRIC ACID2968PHW8QPIACT

Complete SPL Sections#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Sodium fluoride 0.22% (0.10% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Purpose Anticavity

Use

INDICATIONS & USAGE SECTION

Use Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Warnings

Directions

DOSAGE & ADMINISTRATION SECTION

Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor children under 6 years of age instruct in good brushing habits (to minimize swallowing). Supervise as necessary until capable or using without supervision children under 2 years of age consult with a dentist or doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients Water, Sorbitol, Sodium Cocoyl Glutamate, Glycerin, PEG-400, Sucralose, Flavor, Citric Acid, Beta-Glucan, Sodium Bicarbonate, Sodium Benzoate, Sodium Ascorbyl Phosphate, Stevioside, Menthol, Calcium Citrate

Questions or comments

OTC - QUESTIONS SECTION

Questions or comments? Tel: 1(888)509-0459 - Email: support@willo.com Visit us at www.willo.com

Broken seal warning

OTHER SAFETY INFORMATION

Do not use if seal under cap is broken or missing

Flavor description

SPL UNCLASSIFIED SECTION

MINT FLAVOR

Free of claims

SPL UNCLASSIFIED SECTION

Dye free SLS free Sulfate free Paraben free Gluten free

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Willo Minty Mist Anticavity Fluoride Liquid Toothpaste Helps Prevent Cavities & Strengthens Enamel 8 fl oz (237 ml) Scan code to buy another bottle Dist. by: Willo 32, Ince New York, NY 10006 1 (888) 509-0459

Source Document#

Source XML