5820060 Rite Aid Sensitivity And Gum (8015053)

5820060 Rite Aid Sensitivity And Gum (8015053)
SPL v5
SPL
SPL Set ID ed362e9c-2dab-1102-e053-2a95a90a76f3
Route
DENTAL
Published
Effective Date 2022-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-11 Until 2027-01-01

Description

Stannous Fluoride 0.454% w/w (0.15% w/v fluoride ion) ...... Acticavity, Antigingivitis, Anithypersensitivity


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 may indicate a serious problem that may need prompt care by a dentist. Pain/sensitivity still persists after 4 weeks of use. Gingivitis, bleeding, or redness persists for more than 2 weeks. You have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Indications and Usage

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 1 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.

Dosage and Administration

Aids in the prevention of dental cavities. Helps interfere with the harmful effects of plaque associated with gingivitis. 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) ...... Acticavity, Antigingivitis, Anithypersensitivity

Section 50565-1

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

Section 51727-6

glycerin, water, hydrated silica, petasodium tryiphosphate, flavor, sodium lauryl sulfate, titanium dioxide, cellulose gum, cocamiodpropyl betaine, 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 prevent staining. Store below 30C or 86F.

Section 55106-9

Stannous Fluoride 0.454% w/w (0.15% w/v fluoride ion) ...... Acticavity, Antigingivitis, Anithypersensitivity


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 product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 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.

Dosage and Administration (34068-7)

Aids in the prevention of dental cavities. Helps interfere with the harmful effects of plaque associated with gingivitis. 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 may indicate a serious problem that may need prompt care by a dentist. Pain/sensitivity still persists after 4 weeks of use. Gingivitis, bleeding, or redness persists for more than 2 weeks. You have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

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 poision control center right away.

Section 51727-6 (51727-6)

glycerin, water, hydrated silica, petasodium tryiphosphate, flavor, sodium lauryl sulfate, titanium dioxide, cellulose gum, cocamiodpropyl betaine, 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 prevent staining. Store below 30C or 86F.

Section 55106-9 (55106-9)

Stannous Fluoride 0.454% w/w (0.15% w/v fluoride ion) ...... Acticavity, Antigingivitis, Anithypersensitivity


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)