Pearl White Sensitivity Whitening Toothpaste

Pearl White Sensitivity Whitening Toothpaste
SPL v2
SPL
SPL Set ID 51c79544-9536-5863-e054-00144ff8d46c
Route
DENTAL
Published
Effective Date 2017-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1 mg)
Inactive Ingredients
Sorbitol Hydrated Silica Water Propanediol Sodium Lauryl Sulfate Polyethylene Glycol 400 Hydroxyethyl Cellulose (5000 Mpa.s At 1%) Gaultheria Procumbens Leaf Sodium Benzoate Titanium Dioxide Saccharin Sodium Calcium Peroxide Starch, Corn Polyethylene Glycol 1450 Carboxymethylcellulose Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-06-12 Until 2026-11-27
Description

Drug Facts

Medication Information

Warnings and Precautions



Warnings

Indications and Usage

Uses

  • Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets or contact.
  • Aids in the prevention of dental cavities.
Dosage and Administration

Directions

Adults and Children 12 years of age and older

  • Apply at least a 1-inch strip of toothpaste onto a soft bristle toothbrush.
  • Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as directed by a dentist or doctor.
  • Do not swallow. Spit out after brushing.

Children under 12 years of age: Consult a dentist or doctor.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

Stop use and ask a dentist if

  • The problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • Pain/sensitivity still persists after 4 weeks of use.
Section 51727-6

Inactive ingrediets

sorbitol, hydrated silica, aqua, propanediol, PEG1450, sodium lauryl sulfate, PEG 400, gaultheria procumbens leaf extract, zea mays starch, calcium peroxide, sodium carboxymethyl cellulose, titanium dioxide, hydroxyethylcellulose, sodium saccharin, sodium benzoate.

Section 51945-4

PEARL WHITE

SENSITIVITY WHITENING TOOTHPASTE

with Fluoride

NET WT. 4.76 OZ. (135 g)

Section 53413-1

Questions or comments? 866-695-6452

Section 55105-1

Purpose

Antihypersensitivity

Anticavity

Section 55106-9

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.24% (0.10% w/v Fluoride Ion)

Structured Label Content

Indications and Usage (34067-9)

Uses

  • Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets or contact.
  • Aids in the prevention of dental cavities.
Dosage and Administration (34068-7)

Directions

Adults and Children 12 years of age and older

  • Apply at least a 1-inch strip of toothpaste onto a soft bristle toothbrush.
  • Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as directed by a dentist or doctor.
  • Do not swallow. Spit out after brushing.

Children under 12 years of age: Consult a dentist or 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 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.

Section 50566-9 (50566-9)

Stop use and ask a dentist if

  • The problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • Pain/sensitivity still persists after 4 weeks of use.
Section 51727-6 (51727-6)

Inactive ingrediets

sorbitol, hydrated silica, aqua, propanediol, PEG1450, sodium lauryl sulfate, PEG 400, gaultheria procumbens leaf extract, zea mays starch, calcium peroxide, sodium carboxymethyl cellulose, titanium dioxide, hydroxyethylcellulose, sodium saccharin, sodium benzoate.

Section 51945-4 (51945-4)

PEARL WHITE

SENSITIVITY WHITENING TOOTHPASTE

with Fluoride

NET WT. 4.76 OZ. (135 g)

Section 53413-1 (53413-1)

Questions or comments? 866-695-6452

Section 55105-1 (55105-1)

Purpose

Antihypersensitivity

Anticavity

Section 55106-9 (55106-9)

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.24% (0.10% w/v Fluoride Ion)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:24.390578 · Updated: 2026-03-14T23:01:55.379030