5820074 Publix Enamel Guard Intensive (8015074)

5820074 Publix Enamel Guard Intensive (8015074)
SPL v6
SPL
SPL Set ID 16ee2625-3641-205d-e063-6394a90a742f
Route
ORAL
Published
Effective Date 2024-09-04
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
Water Saccharin Sodium Titanium Dioxide Xanthan Gum Hydrated Silica Sodium Hydroxide Cocamidopropyl Betaine Polyethylene Glycol 400 Sorbitol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-01

Description

potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)


Medication Information

Warnings and Precautions

When using this product, of iffitation occurs discontine use.

Stop use and ask a dentist if the problem persists or worsen. Sensitive teeth may indicate a serious problem that many need prompt care by a dentist.* pain/sensitivty still persists after 4 weeks of use.

Indications and Usage

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

adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto 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% Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Section 50565-1

Keep out of reach of children. If more than used for brushing is accidently 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

Antihypersensitivity

Anticavity

Section 55106-9

potassium nitrate 5%

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


Structured Label Content

Indications and Usage (34067-9)

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)

adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto 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, of iffitation occurs discontine use.

Stop use and ask a dentist if the problem persists or worsen. Sensitive teeth may indicate a serious problem that many need prompt care by a dentist.* pain/sensitivty still persists after 4 weeks of use.

Section 50565-1 (50565-1)

Keep out of reach of children. If more than used for brushing is accidently 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)

Antihypersensitivity

Anticavity

Section 55106-9 (55106-9)

potassium nitrate 5%

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)