5820206 Rite Aid Enamel Guard (8015164)

5820206 Rite Aid Enamel Guard (8015164)
SPL v25
SPL
SPL Set ID 67c1fc04-0f21-4944-8b9d-0d8ffd051874
Route
DENTAL
Published
Effective Date 2019-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.15 g) Nitrite Ion (5 g)
Inactive Ingredients
Glycerin Saccharin Sodium Water Sodium Hydroxide Xanthan Gum Cocamidopropyl Betaine Polyethylene Glycol, Unspecified Hydrated Silica Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-06-03 Until 2027-01-24
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

If pain/sensitivity persists after 4 weeks of use, please visit your dentist.

Indications and Usage

Uses

  • aids in the prevention of dental caviites
  • aids in reducing sensitivity
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 bristle toothbruch.

  • Brush teeth thorughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as directed by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • Children under 12 years of age: consult a dentist or doctor.
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Store in a cool, dry place.

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 50566-9

Stop use and see your doctor if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Section 51727-6

Inactive ingredients water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidpropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

Section 51945-4

Section 55105-1

Purpose

Antihypersensitivity

Anticavity

Section 55106-9

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.15% w/v fluoride ion

Structured Label Content

Indications and Usage (34067-9)

Uses

  • aids in the prevention of dental caviites
  • aids in reducing sensitivity
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 bristle toothbruch.

  • Brush teeth thorughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as directed by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • Children under 12 years of age: consult a dentist or doctor.
Warnings and Precautions (34071-1)

Warnings

If pain/sensitivity persists after 4 weeks of use, please visit your dentist.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Store in a cool, dry place.

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 50566-9 (50566-9)

Stop use and see your doctor if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Section 51727-6 (51727-6)

Inactive ingredients water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidpropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

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 0.15% w/v fluoride ion

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:18.964007 · Updated: 2026-03-14T23:10:38.535907