5820001 Topco Restore & Defend

5820001 Topco Restore & Defend
SPL v6
SPL
SPL Set ID 96384c9d-cb42-7654-e053-2995a90aac08
Route
DENTAL
Published
Effective Date 2019-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-31

Description

Active Ingredient Purpose Stannous fluoride 0.454% (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 may indicate a serious problem that may need prompt care by a dentist
  • pain/sensitivity still persists after 4 weeks of use

Description

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

Uses
  • aids in the prevention of dental cavities
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
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, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin

Section 51945-4

Whitening

Sensitive

Anticavity Toothpaste for Sensitive Teeth

Net Wt 3.4 oz (96.3g)

Compare to Sensodyne

Repair & Protect Active Ingredient*

Restore

& Defend

Builds protective coating on

sensitive areas of teeth

Section 55106-9

Active Ingredient Purpose

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

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 twise 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.
Other Information

products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing 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 30°C (86°F)


Structured Label Content

Uses
  • 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 may 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 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, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin

Section 51945-4 (51945-4)

Whitening

Sensitive

Anticavity Toothpaste for Sensitive Teeth

Net Wt 3.4 oz (96.3g)

Compare to Sensodyne

Repair & Protect Active Ingredient*

Restore

& Defend

Builds protective coating on

sensitive areas of teeth

Section 55106-9 (55106-9)

Active Ingredient Purpose

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

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 twise 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.
Other Information (Other information)

products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing 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 30°C (86°F)


Advanced Ingredient Data


Raw Label Data

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