5820278 Cvs Pro Defense Whitening

5820278 Cvs Pro Defense Whitening
SPL v9
SPL
SPL Set ID 445ec57e-dc3c-49a0-8ca9-4806fcdc0303
Route
DENTAL
Published
Effective Date 2017-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.454 g)
Inactive Ingredients
Glycerin Saccharin Sodium Water Sodium Tripolyphosphate Anhydrous Titanium Dioxide Carboxymethylcellulose Sodium Hydrated Silica Cocamidopropyl Betaine Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-06-01 Until 2024-08-31

Description

Active ingredient Stannous Fluoride (0.454% w/w)


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • aids in the prevention of dental cavities
  • helps control bleeding gums
  • helps interfere with harmful effects of plaque associated with gingivitis
Dosage and Administration

Directions

Adults and children 2 years of age and older:

  • Brush teeth thoroughly preferably after each meal or at least twice a day and not more than 3 times a day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
  • To minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing until good habits are established.

Children under 2 years of age: consult a dentist or doctor

Description

Active ingredient Stannous Fluoride (0.454% w/w)

Section 42229-5

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2017 CVS/pharmacy

CVS.com 1-800-SHOP CVS

Section 50565-1

Keep out of reach of children under 6 years of age. 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

  • gingivitis, bleeding or redness persists for more than 2 weeks
  • if 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 periodontis, a serious form of gum disease.
Section 50567-7

When using this product, discontinue use if irritation occurs.

Section 51727-6

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

Section 51945-4

Section 55105-1

Purpose

Anticavity/Antigingiviitis

Section 55106-9

Active ingredient

Stannous Fluoride (0.454% w/w)

Section 60561-8

Other information

  • products containing Stannous Fluoride may cause 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 specially formulated to help prevent staining.
  • Store below 77F (25C)
  • Keep tube capped when not in use.

Structured Label Content

Indications and Usage (34067-9)

Uses

  • aids in the prevention of dental cavities
  • helps control bleeding gums
  • helps interfere with harmful effects of plaque associated with gingivitis
Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older:

  • Brush teeth thoroughly preferably after each meal or at least twice a day and not more than 3 times a day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
  • To minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing until good habits are established.

Children under 2 years of age: consult a dentist or doctor

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2017 CVS/pharmacy

CVS.com 1-800-SHOP CVS

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. 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

  • gingivitis, bleeding or redness persists for more than 2 weeks
  • if 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 periodontis, a serious form of gum disease.
Section 50567-7 (50567-7)

When using this product, discontinue use if irritation occurs.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Anticavity/Antigingiviitis

Section 55106-9 (55106-9)

Active ingredient

Stannous Fluoride (0.454% w/w)

Section 60561-8 (60561-8)

Other information

  • products containing Stannous Fluoride may cause 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 specially formulated to help prevent staining.
  • Store below 77F (25C)
  • Keep tube capped when not in use.

Advanced Ingredient Data


Raw Label Data

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