5820083 Kroger Restore & Defend Whitening (80-15274)

5820083 Kroger Restore & Defend Whitening (80-15274)
SPL v6
SPL
SPL Set ID 253ba5c0-f2ef-46e6-e063-6394a90ad9d5
Route
DENTAL
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.15 g)
Inactive Ingredients
Sodium Tripolyphosphate Anhydrous Carboxymethylcellulose Sodium Cocamidopropyl Betaine Hydrated Silica Sodium Lauryl Sulfate Glycerin Water Saccharin Sodium Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-18

Description

Stannous fluoride 0.454% (0.15% w/v fluoride ion)


Medication Information

Warnings and Precautions

When using this product, if irritation occurs discontinue use.

Stop using 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/sensitivty still persists after 4 weeks of use

Keep out of reach of children.

Indications and Usage

aids in the prevention of dental cavities

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

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 toothbrush • brush teeth thoroughly for at least one minute, preferably after each emal or at least twice a day (morning and evening) or as recommended by a dentist or physician.

Make sure to brush all sensitive areas of the teeth. Do not swallow. • children under 12 years of age: Consult a dentist or doctor.

Description

Stannous fluoride 0.454% (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 Control Center right away.

Section 51727-6

glycerin, water, hydrated silica, pentasodium triphosphate, cellulose gum, cocamidopropyl betaine, flavor, sodium lauryl sulfate, titanium dioxide, sodium saccharin

Section 51945-4

Section 55105-1

Anticavity, Antihypersensitivity

Section 55106-9

Stannous fluoride 0.454% (0.15% w/v fluoride ion)


Structured Label Content

Indications and Usage (34067-9)

aids in the prevention of dental cavities

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

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 toothbrush • brush teeth thoroughly for at least one minute, preferably after each emal or at least twice a day (morning and evening) or as recommended by a dentist or physician.

Make sure to brush all sensitive areas of the teeth. Do not swallow. • 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 using 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/sensitivty still persists after 4 weeks of use

Keep out of reach of children.

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 51727-6 (51727-6)

glycerin, water, hydrated silica, pentasodium triphosphate, cellulose gum, cocamidopropyl betaine, flavor, sodium lauryl sulfate, titanium dioxide, sodium saccharin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity, Antihypersensitivity

Section 55106-9 (55106-9)

Stannous fluoride 0.454% (0.15% w/v fluoride ion)


Advanced Ingredient Data


Raw Label Data

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