5820293 Care One Restore & Defend Sensitive Whitening Toothpaste

5820293 Care One Restore & Defend Sensitive Whitening Toothpaste
SPL v7
SPL
SPL Set ID 81a380eb-8605-b280-e053-2a91aa0abd4b
Route
DENTAL
Published
Effective Date 2019-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-11

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

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 directed 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

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 by 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

CareOne®

RESTORE & DEFEND SENSITIVE TOOTHPASTE

FOR SENSITIVE TEETH & CAVITY PROTECTION

DAILY PROTECTION FOR SENSITIVE TEETH

WHITENING

FRESH MINT

NET WT 3.4 OZ (96.3 g)

Section 53413-1

Questions or Comments? CALL 1-877-846-9949

Section 55105-1

Purpose

Anticavity/Antihypersensitivity

Section 55106-9

Active ingredient

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


Structured Label Content

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 directed 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 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 by 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)

CareOne®

RESTORE & DEFEND SENSITIVE TOOTHPASTE

FOR SENSITIVE TEETH & CAVITY PROTECTION

DAILY PROTECTION FOR SENSITIVE TEETH

WHITENING

FRESH MINT

NET WT 3.4 OZ (96.3 g)

Section 53413-1 (53413-1)

Questions or Comments? CALL 1-877-846-9949

Section 55105-1 (55105-1)

Purpose

Anticavity/Antihypersensitivity

Section 55106-9 (55106-9)

Active ingredient

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)