5820052 Sensitive Restore & Defend Whitening (8015274)

5820052 Sensitive Restore & Defend Whitening (8015274)
SPL v8
SPL
SPL Set ID c4807b2b-7ea9-cc28-e053-2995a90a348e
Route
DENTAL
Published
Effective Date 2021-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-23

Description

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


Medication Information

Warnings and Precautions

When using this product, if irriation occurs discontinue use.

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

adults and children 12 years of age or older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush * brush teeth thoroughly for at least one minute, preferrably after each meal 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% w/w (0.15% w/v fluoride ion)

Section 50565-1

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

Section 50566-9

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 still persists after 4 weeks of use.
Section 51727-6

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

Section 51945-4

Section 55105-1

Anticavity / Antihypersensitivity

Section 55106-9

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

Section 60561-8

products containing stannous fluoride may produce surface staining of the teeth. Adequade tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. * this product is specifically formulated to help prevent staining. * store below 30ºC (86ºF)


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)

adults and children 12 years of age or older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush * brush teeth thoroughly for at least one minute, preferrably after each meal 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 irriation occurs discontinue use.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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 still persists after 4 weeks of use.
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity / Antihypersensitivity

Section 55106-9 (55106-9)

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

Section 60561-8 (60561-8)

products containing stannous fluoride may produce surface staining of the teeth. Adequade tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. * this product is specifically formulated to help prevent staining. * store below 30ºC (86ºF)


Advanced Ingredient Data


Raw Label Data

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