5820081 Target Sensitive Whitening Tp (8015201)

5820081 Target Sensitive Whitening Tp (8015201)
SPL v7
SPL
SPL Set ID ab9a129e-337b-31fe-e053-2995a90ac691
Route
DENTAL
Published
Effective Date 2020-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (5 g) Fluoride Ion (0.24 g)
Inactive Ingredients
Hydrated Silica Water Sorbitol Cocamidopropyl Betaine Saccharin Sodium Tripolyphosphate Anhydrous Polyethylene Glycol 400 Titanium Dioxide Sodium Hydroxide Glycerin Xanthan Gum Sodium Methyl Cocoyl Taurate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-01 Until 2024-02-24

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 use. Stop use and ask a doctor if * the problem persists or worsens. 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 * 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 0.24% (0.15% w/v fluoride ion)

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. If more than is 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 cocoyl taurate, cocomidopropyl 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)

Section 60561-8

store below 30C (86F)


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, if irritation occurs discontinue use. Stop use and ask a doctor if * the problem persists or worsens. 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 is 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 cocoyl taurate, cocomidopropyl 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)

Section 60561-8 (60561-8)

store below 30C (86F)


Advanced Ingredient Data


Raw Label Data

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