FDA.reportPublic FDA data

Hey Humans Whitening Clean Mint Rush

Manufacturer
Maesa LLC | Nutrix International LLC
Effective date
2021-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:41

Label at a glance#

ProductHey Humans Whitening Clean Mint Rush
Active ingredientSodium Fluoride
Label structure10 sections

Indications and uses

Helps protect against cavities.

Dosage and administration

Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. Children 2 to 6 years: To minimize swallowing, use only a pea-sized amount. Supervise children's brushing and rinsing until good habits are established. Children under 2 years of age: Consult a dentist or physician.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.25% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

  • Helps protect against cavities.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children under 6 years of age.
  • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and older:
    • Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
  • Children 2 to 6 years:
    • To minimize swallowing, use only a pea-sized amount.
    • Supervise children's brushing and rinsing until good habits are established.
  • Children under 2 years of age: Consult a dentist or physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Sorbitol, Hydrated Silica, Water, Xylitol, Cocamidopropyl Betaine, Flavor, Sodium Cocoyl Glutamate, Xanthan Gum, Stevia Rebaudiana Leaf/Stem Extract, Cellulose Gum, Menthol, Squalene.

Questions or Comments

OTC - QUESTIONS SECTION

You may report an adverse reaction to: HEY HUMANS c/o Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: MAESA LLC
225 LIBERTY STREET,
NEW YORK, NY 10281.

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Naturally Derived
Toothpaste

With Fluoride

Hey
Humans

With Everice™
Technology

WHITENING

Long-lasting fresh breath,
anticavity, anti-plaque,
anti-tartar

Clean Mint
Rush

Artificial sweetener,
phthalate, paraben
& sulfate free

NET WT. 96 g / 3.4 OZ.

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton
PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044547sodium fluoride 0.25 % ToothpastePSN1
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCD1
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSY1
1044547sodium fluoride 0.25 % ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71899-200-012023-01-30C16284748780-1f386c64a-0c49-0266-e053-dadaa90a7c1aHey Humans Whitening Clean Mint Rush

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71899-200-01Hey Humans Whitening Clean Mint Rush96 g in 1 TUBEPASTE, DENTIFRICE961
71899-200-01Hey Humans Whitening Clean Mint Rush1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71899-200HEY HUMANS WHITENING CLEAN MINT RUSH (SODIUM FLUORIDE) PASTE, DENTIFRICE [MAESA LLC]1Legacy NDC, 2 package rows20210303_79137d9a-db85-4e65-9490-a1d13510ab80.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71899-20071899-200-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium Fluoride8ZYQ1474W7ACTIM
GlycerinPDC6A3C0OXIACT
Sorbitol506T60A25RIACT
Hydrated SilicaY6O7T4G8P9IACT
Water059QF0KO0RIACT
XylitolVCQ006KQ1EIACT
Cocamidopropyl Betaine5OCF3O11KXIACT
Sodium Cocoyl GlutamateBMT4RCZ3HGIACT
Xanthan GumTTV12P4NEEIACT
Stevia Rebaudiuna Leaf6TC6NN0876IACT
Carboxymethylcellulose Sodium, UnspecifiedK679OBS311IACT
Menthol, Unspecified FormL7T10EIP3AIACT
Squalene7QWM220FJHIACT

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
2dd09626-6704-4128-9089-3f1f82261bb379137d9a-db85-4e65-9490-a1d13510ab802021-03-01WarningsExact identifier
spl id: 2dd09626-6704-4128-9089-3f1f82261bb3
spl set id: 79137d9a-db85-4e65-9490-a1d13510ab80

Reported adverse events (FAERS/openFDA)#

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