5820076 Rite Aid Enamel Guard Intensive (8015074)

5820076 Rite Aid Enamel Guard Intensive (8015074)
SPL v3
SPL
SPL Set ID 21645dd5-5cb7-2088-e063-6394a90a61ff
Route
DENTAL
Published
Effective Date 2024-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

Potassium nitrate 5% .................................................. Antihypersensitivity Sodium fluoride 0.25% (0.15% w/v fluoride ion).......... Anticavity


Medication Information

Warnings and Precautions

When using this product, if irritation occurs discontinue use.

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 stil persists after 4 weeks of use.

Indications and Usage

builds increasing protection against painful sensitivty of the teeth to cold, acids, sweets, or contact. Aids in the prevention of dental cavities.

Dosage and Administration

adults and children 12 years of age and older: apply at least a 1-inch strip of the product ontp a soft bristle toothbrush. Brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. 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 doctor.

Description

Potassium nitrate 5% .................................................. Antihypersensitivity Sodium fluoride 0.25% (0.15% w/v fluoride ion).......... Anticavity

Section 50565-1

If more than used for brushing is accidentaly swallowed, get medical help or contact a Posion Control Center right away.

Section 51727-6

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

Section 51945-4

Section 55105-1

Anthihypersensitivity

Anticavity

Section 55106-9

Potassium nitrate 5% .................................................. Antihypersensitivity

Sodium fluoride 0.25% (0.15% w/v fluoride ion).......... Anticavity


Structured Label Content

Indications and Usage (34067-9)

builds increasing protection against painful sensitivty of the teeth to cold, acids, sweets, or contact. Aids in the prevention of dental cavities.

Dosage and Administration (34068-7)

adults and children 12 years of age and older: apply at least a 1-inch strip of the product ontp a soft bristle toothbrush. Brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. 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 doctor.

Warnings and Precautions (34071-1)

When using this product, if irritation occurs discontinue use.

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 stil persists after 4 weeks of use.

Section 50565-1 (50565-1)

If more than used for brushing is accidentaly swallowed, get medical help or contact a Posion Control Center right away.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anthihypersensitivity

Anticavity

Section 55106-9 (55106-9)

Potassium nitrate 5% .................................................. Antihypersensitivity

Sodium fluoride 0.25% (0.15% w/v fluoride ion).......... Anticavity


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)