5820007 cvs restore & defend sensitive whitening toothpaste

5820007 cvs restore & defend sensitive whitening toothpaste
SPL v6
SPL
SPL Set ID 81b72da2-7f41-74ca-e053-2a91aa0a9646
Route
dental
Published
Effective Date 2019-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.454 g)
Inactive Ingredients
water saccharin sodium titanium dioxide sodium lauryl sulfate glycerin hydrated silica cocamidopropyl betaine sodium tripolyphosphate anhydrous carboxymethylcellulose sodium, unspecified form

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-02-11

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredient

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

Indications and Usage

Uses

  • aids in the prevention of dental cavities
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
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 physican. 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

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

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 your dentist.
  • This product is specifically formulated to help prevent staining
  • store below 30°C (86°F)
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 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 of use
Section 50567-7

When using this product, if irritation occurs discontinue use.

Section 51727-6

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

Section 51945-4

CVS Health™

RESTORE & DEFEND

SENSITIVE ANTICAVITY TOOTHPASTE WITH FLUORIDE

For sensitive teeth & cavity protection

Whitening

Fresh Mint

NET WT 3.4 OZ (96.4 g)

Section 55105-1

Purpose

Anticavity / Antihypersensitivity


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredient

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

Indications and Usage (34067-9)

Uses

  • aids in the prevention of dental cavities
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
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 physican. Make sure to brush all sensitive areas of the teeth.
  • Do not swallow
  • Children under 12 years of age: consult a dentist or doctor
Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

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 your dentist.
  • This product is specifically formulated to help prevent staining
  • store below 30°C (86°F)
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 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 of use
Section 50567-7 (50567-7)

When using this product, if irritation occurs discontinue use.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

CVS Health™

RESTORE & DEFEND

SENSITIVE ANTICAVITY TOOTHPASTE WITH FLUORIDE

For sensitive teeth & cavity protection

Whitening

Fresh Mint

NET WT 3.4 OZ (96.4 g)

Section 55105-1 (55105-1)

Purpose

Anticavity / Antihypersensitivity


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)