5820251 Cvs Restore & Defend Sensitive Fresh Mint

5820251 Cvs Restore & Defend Sensitive Fresh Mint
SPL v10
SPL
SPL Set ID 99f86135-05b7-42b1-aef5-df4513259b8f
Route
DENTAL
Published
Effective Date 2016-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-01
Description

Active ingredient Stannous Fluoride (0.454% w/w)

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • builds increasing protection against painful sensitivity of the teeth
  • aids in the prevention of dental cavities
Dosage and Administration

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, 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
Description

Active ingredient Stannous Fluoride (0.454% w/w)

Section 50565-1

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

Section 50566-9

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
Section 51727-6

Inactive ingredients water, glycerin, hydrated silica, sodium tripolyphosphate, sodium saccharin, titanium dioxide, cellulose gum, cocamidopropyl betaine, sodium lauryl sulfate, flavor

Section 51945-4

Section 55105-1

Purpose

Anticavity/Antihypersensitivity

Section 55106-9

Active ingredient

Stannous Fluoride (0.454% w/w)

Structured Label Content

Indications and Usage (34067-9)

Uses

  • builds increasing protection against painful sensitivity of the teeth
  • aids in the prevention of dental cavities
Dosage and Administration (34068-7)

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, 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
Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 51727-6 (51727-6)

Inactive ingredients water, glycerin, hydrated silica, sodium tripolyphosphate, sodium saccharin, titanium dioxide, cellulose gum, cocamidopropyl betaine, sodium lauryl sulfate, flavor

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Anticavity/Antihypersensitivity

Section 55106-9 (55106-9)

Active ingredient

Stannous Fluoride (0.454% w/w)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:13.165955 · Updated: 2026-03-14T23:10:28.026216