Made by Dentists For Kids Eyeball Juice

Manufacturer
Fulijaya Manufacturing Sdn. Bhd
Effective date
2025-06-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:03:52

Label at a glance#

ProductMade by Dentists For Kids Eyeball Juice
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

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. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing), and only use a pea size amount. Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentis...

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use:

INDICATIONS & USAGE SECTION

Aids in the prevention of cavities.

Warnings:

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

  • 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.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing), and only use a pea size amount.
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Sorbitol, Water (Aqua), Hydrated Silica, Glycerin, Xylitol, Cellulose Gum, Cocamidopropyl Betaine, Potassium Sorbate, Stevia Rebaudiana Leaf Extract, Flavor, Ipomoea Batatas Root Extract, Maltodextrin

Questions or comments?

OTC - QUESTIONS SECTION

+ 1 (646) 980-6461

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

inside labelinside label

LabelLabelLabel 2Label 2

Label: 62776-001-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label tubeLabel tube

Label 2Label 2Label 1Label 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850031970366GTIN-13: 0850031970366
EAN-13: 0850031970366
GTIN-12: 850031970366
UPC-A: 850031970366
GTIN storage (14 digits): 00850031970366
Labell.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62776-001-01Made by Dentists For Kids Eyeball Juice120 g in 1 TUBEPASTE1203
62776-001-01Made by Dentists For Kids Eyeball Juice1 in 1 CARTONPASTE13
62776-001-02Made by Dentists For Kids Eyeball Juice20 g in 1 TUBEPASTE203
62776-001-02Made by Dentists For Kids Eyeball Juice1 in 1 CARTONPASTE13

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62776-00162776-001-01, 62776-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
386bbb8b-dccf-19f9-e063-6294a90a162d17681a6e-bb16-9651-e063-6294a90af1162025-06-25WarningsExact identifier
spl id: 386bbb8b-dccf-19f9-e063-6294a90a162d
spl set id: 17681a6e-bb16-9651-e063-6294a90af116

Reported adverse events (FAERS/openFDA)#

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