5820257 Equate Sensitive Toothpaste With Fluoride

5820257 Equate Sensitive Toothpaste With Fluoride
SPL v8
SPL
SPL Set ID 79899b59-3a16-6504-e053-2991aa0a895a
Route
DENTAL
Published
Effective Date 2025-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (5 g) Fluoride Ion (0.15 g)
Inactive Ingredients
Glycerin Sodium Methyl Cocoyl Taurate Saccharin Xanthan Gum Sodium Hydroxide Hydrated Silica Tripolyphosphate Ion Sorbitol Titanium Dioxide Water Cocamidopropyl Betaine Polyethylene Glycol 400

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-02

Description

Active ingredients Potassium nitrate 5% Sodium fluoride 0.24% (0.15% w/v fluoride ion)


Medication Information

Warnings and Precautions

Warnings

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. See your dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Indications and Usage

Uses

  • builds increasing protection against 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 the product onto a soft britsle toothbrush. · Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

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

Description

Active ingredients Potassium nitrate 5% Sodium fluoride 0.24% (0.15% w/v fluoride ion)

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

water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyltaurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin

Section 51945-4

Section 55105-1

Purpose

Antihypersensitivity

Anticavity

Section 55106-9

Active ingredients

Potassium nitrate 5%

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


Structured Label Content

Indications and Usage (34067-9)

Uses

  • builds increasing protection against 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 the product onto a soft britsle toothbrush. · Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

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

Warnings and Precautions (34071-1)

Warnings

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. See your dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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)

water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyltaurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antihypersensitivity

Anticavity

Section 55106-9 (55106-9)

Active ingredients

Potassium nitrate 5%

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)