Spotlight Pregnancy

Manufacturer
Oral Spotlight Care Inc
Effective date
2023-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:39:56

Label at a glance#

ProductSpotlight Pregnancy
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient  Sodium Fluoride 0.24%

OTC - PURPOSE SECTION

Purpose  Anticavity

INDICATIONS & USAGE SECTION

Use  aids in the prevention of dental decay.

WARNINGS SECTION

Warnings

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.

DOSAGE & ADMINISTRATION SECTION

Directions • adults and children 2 years of age and older:
older: Brush teeth vithouroughly, 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 SECTION

Inactive Ingredients

Sorbitol, Water (purified), Hydrated Silica, Pentasodium

Triphosphate, Sodium Bicarbonate, Cocamidopropyl Betaine,

Cellulose Gum, Titanium Dioxide, Flavor, Cyanocobalamin,

Folic Acid, Calcium Gluconate, Sodium Saccharin

OTC - QUESTIONS SECTION

Questions?  +1 (646) 9806461

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spotlight

Oral Care

CREATED BY DENTISTS

 Pregnancy

Toothpaste

Mild Mint Flavor

Contains

Fluoride | Calcium Gluconate

Cyanocobalamin | Folic Acid

Fluoride Anticavity

Pregnancy Toothpaste

NET WT 3.5oz (100g)

MADE IN THE USA

Spotlight Oral Care, 90 South Dale, Suite #8

Saint Paul, Minnesota, USA 55102

Preg TPastePreg TPaste

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75065-00475065-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
a5c32136-2d8d-4bd0-b01b-ef0048fd52342ff05a69-5d47-4f34-b6a1-9a9fe35f43bb2023-01-18WarningsExact identifier
spl id: a5c32136-2d8d-4bd0-b01b-ef0048fd5234
spl set id: 2ff05a69-5d47-4f34-b6a1-9a9fe35f43bb

Reported adverse events (FAERS/openFDA)#

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