5820055 Ra Complete Protection

5820055 Ra Complete Protection
SPL v8
SPL
SPL Set ID ccad28b5-254e-679f-e053-2a95a90abdd5
Route
DENTAL
Published
Effective Date 2021-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-26 Until 2027-01-01

Description

Stannous fluoride 0.454% w/w (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 dentist if: * the problems 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 teh 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

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

Dosage and Administration

adults and children 12 years of age adn 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.

Description

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

Section 50565-1

Keep out of reach of children. If more than used from brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

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

Section 51945-4

Section 55105-1

Anticavity, Antigingivitis, 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. Adequate 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 30*C (86*F)


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

adults and children 12 years of age adn 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.

Warnings and Precautions (34071-1)

When using this product, if irritation occurs discontinue use.

Stop use and ask a dentist if: * the problems 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 teh 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 from 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, sodium lauryl sulfate, flavor, cellulose gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity, Antigingivitis, 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. Adequate 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 30*C (86*F)


Advanced Ingredient Data


Raw Label Data

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