5820065 Up&up Sensitive Complete Protection Tp

5820065 Up&up Sensitive Complete Protection Tp
SPL v8
SPL
SPL Set ID 03708e08-0189-b83d-e063-6394a90a50e6
Routes
ORAL DENTAL
Published
Effective Date 2025-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-10 Until 2028-08-31

Description

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

Purpose

Anticavity, Antigingivitis, Antihypersensitivity


Medication Information

Purpose

Anticavity, Antigingivitis, Antihypersensitivity

Description

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

Warnings

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.

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 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.
Active Ingredient

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

Other Information

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.
Indications & 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

Inactive Ingredients

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

Principal Display Panel

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.


Structured Label Content

Purpose

Anticavity, Antigingivitis, Antihypersensitivity

Warnings

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.

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 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.
Active Ingredient

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

Other Information (Other information)

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.
Indications & 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

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

Keep Out of Reach of Children (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.


Advanced Ingredient Data


Raw Label Data

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