5820059 Walgreens Sensitive Restore & Defend Whitening (8015223)

5820059 Walgreens Sensitive Restore & Defend Whitening (8015223)
SPL v7
SPL
SPL Set ID e808ea4b-9081-085b-e053-2a95a90a4f9b
Route
DENTAL
Published
Effective Date 2022-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-28

Description

Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion) .... Anticavity/Antihypersensitivity


Medication Information

Warnings and Precautions

When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth pay indicate a serious problem that may need prompt care by a dentist. Pain/sensitivity still persists after 4 weeks of use.

Indications and Usage

Adults and children 12 years of age and older: apply at least a 1-inch strip of the produc tonto a soft bristle toothbrush. brush teeth thoroughly for at least one minute, preferably 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.

Dosage and Administration

Aids in the prevention of dental cavities. Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

Description

Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion) .... Anticavity/Antihypersensitivity

Section 50565-1

Keep out of reach of children. If more than used for bushing is accidentally swallowed, get medical help or contact a poison control center right away.

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

Products containing stannous fluoride may produce surface staining of the teeth. Adquate 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 30C (86F).

Section 55106-9

Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion) .... Anticavity/Antihypersensitivity


Structured Label Content

Indications and Usage (34067-9)

Adults and children 12 years of age and older: apply at least a 1-inch strip of the produc tonto a soft bristle toothbrush. brush teeth thoroughly for at least one minute, preferably 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.

Dosage and Administration (34068-7)

Aids in the prevention of dental cavities. Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

Warnings and Precautions (34071-1)

When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth pay 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 bushing 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, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Products containing stannous fluoride may produce surface staining of the teeth. Adquate 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 30C (86F).

Section 55106-9 (55106-9)

Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion) .... Anticavity/Antihypersensitivity


Advanced Ingredient Data


Raw Label Data

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