5820075 Publix Sensitive Extra Whitening (8015201)

5820075 Publix Sensitive Extra Whitening (8015201)
SPL v5
SPL
SPL Set ID 16eddce3-03e4-4c0e-e063-6294a90ae94d
Route
ORAL
Published
Effective Date 2024-09-04
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
Sodium Hydroxide Polyethylene Glycol 400 Hydrated Silica Water Glycerin Sodium Methyl Cocoyl Taurate Cocamidopropyl Betaine Titanium Dioxide Xanthan Gum Sodium Tripolyphosphate Anhydrous Sorbitol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-18

Description

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


Medication Information

Warnings and Precautions

When using this product, if irritation occurs discontinue.

Stop use and ask a dentist if * the problem persists or worsen. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. * pain/sensitivity 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 * acids in the prevention of dental cavities

Dosage and Administration

adults and children 12 years pf 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 0.24% (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 Center right away.

Section 51727-6

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

Section 51945-4

Section 55105-1

Antihypersensitivity

Anticavity

Section 55106-9

Potassium nitrate 5%

Sodium fluoride 0.24% (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 * acids in the prevention of dental cavities

Dosage and Administration (34068-7)

adults and children 12 years pf 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, if irritation occurs discontinue.

Stop use and ask a dentist if * the problem persists or worsen. 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 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 Center right away.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antihypersensitivity

Anticavity

Section 55106-9 (55106-9)

Potassium nitrate 5%

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)