5010479 Nw Radiant White

5010479 Nw Radiant White
SPL v5
SPL
SPL Set ID f0b62aaa-4983-4bd3-931e-f1a31b870f62
Route
DENTAL
Published
Effective Date 2019-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.15 g)
Inactive Ingredients
Polyethylene Glycol, Unspecified Water Saccharin Sodium Sorbitol Titanium Dioxide Sodium Hydroxide Xanthan Gum Hydrated Silica Sodium Acid Pyrophosphate Carboxymethylcellulose Sodium, Unspecified Form Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Sodium Lauryl Sulfate Mica Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-01-01
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use aids in the prevention of dental cavities

Dosage and Administration

Directions

Adults and children 2 years of age and older: brush teeth thorughly 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 avoid swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 12 years of age: consult a dentist or a doctor.
Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 51727-6

Inactive ingredients water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, xanthan gum, carbomer, sodium saccharin, sodium hydroxide, mica, titanium dioxide, blue 1 lake, polyethylene

Section 51945-4

Section 53413-1

Questions or comments? CALL 1-877-777-2743

Section 55105-1

Purpose

Anticavity

Section 55106-9

Active ingredient

Sodium fluoride 0.243%

Structured Label Content

Indications and Usage (34067-9)

Use aids in the prevention of dental cavities

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older: brush teeth thorughly 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 avoid swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 12 years of age: consult a dentist or a doctor.
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, xanthan gum, carbomer, sodium saccharin, sodium hydroxide, mica, titanium dioxide, blue 1 lake, polyethylene

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? CALL 1-877-777-2743

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active ingredient

Sodium fluoride 0.243%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:23.017751 · Updated: 2026-03-14T23:07:05.651363