Made by Dentists For Kids Eyeball Juice (Watermelon) — v4

Made by Dentists For Kids Eyeball Juice (Watermelon)

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Version

v4

Effective date

September 30, 2025

Original packager

Yes

Sections captured

11

Identifiers

Document ID
400683bc-e9e6-c57f-e063-6394a90ab363
Set ID
b2ad2b19-6fdf-454d-9b1d-49b1c81016fd
Application numbers
M021
Product NDCs
75065-024
Package NDCs
75065-024-06
Original packager NDCs
—

Names & Manufacturers

Brand names
Made by Dentists For Kids Eyeball Juice (Watermelon)
Generic names
SODIUM FLUORIDE
Manufacturer names
MADE BY DENTISTS INC
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
SODIUM FLUORIDE
Routes
DENTAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
8ZYQ1474W7
UPC
0850078838032

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient: Sodium Fluoride 0.24% (0.15% w/v fluoride ion) Purpose Anticavity
Dosage And Administration (1)

Sequence 1

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. 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 Ingredient (1)

Sequence 1

Inactive ingredients: Glycerin, Water (Aqua), Hydrated Silica, Cellulose Gum, Flavor, Cocamidopropyl Betaine, Titanium Dioxide, Sodium Saccharin, Potassium Sorbate
Indications And Usage (1)

Sequence 1

Use: Aids in the prevention of cavities.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentlly swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

Label Label tube Label inside label
Purpose (1)

Sequence 1

Purpose Anticavity
Questions (1)

Sequence 1

Questions or comments? + 1 (646) 980-6461
Spl Product Data Elements (1)

Sequence 1

Made by Dentists For Kids Eyeball Juice (Watermelon) SODIUM FLUORIDE WATER HYDRATED SILICA CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED COCAMIDOPROPYL BETAINE POTASSIUM SORBATE SACCHARIN SODIUM SODIUM FLUORIDE FLUORIDE ION GLYCERIN TITANIUM DIOXIDE
Spl Unclassified Section (1)

Sequence 1

Drug Facts
Warnings (1)

Sequence 1

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

OpenFDA raw payload

{'application_number': ['M021'],
 'brand_name': ['Made by Dentists For Kids Eyeball Juice (Watermelon)'],
 'generic_name': ['SODIUM FLUORIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['MADE BY DENTISTS INC'],
 'package_ndc': ['75065-024-06'],
 'product_ndc': ['75065-024'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['DENTAL'],
 'spl_id': ['400683bc-e9e6-c57f-e063-6394a90ab363'],
 'spl_set_id': ['b2ad2b19-6fdf-454d-9b1d-49b1c81016fd'],
 'substance_name': ['SODIUM FLUORIDE'],
 'unii': ['8ZYQ1474W7'],
 'upc': ['0850078838032']}