Crest ®

Crest ®
SPL v7
SPL
SPL Set ID 81dd949b-6fd0-1d88-e053-2991aa0acb18
Route
DENTAL
Published
Effective Date 2019-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.4 mg)
Inactive Ingredients
Hydrated Silica Sorbitol Zinc Citrate Stannous Chloride Water Sodium Lauryl Sulfate Sodium Gluconate Carrageenan Saccharin Sodium Xanthan Gum Titanium Dioxide Sodium Hydroxide Cocamidopropyl Betaine Sucralose

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-09

Description

Drug Facts

Purpose

Anticavity, antigingivitis, antisensitivity toothpaste


Medication Information

Purpose

Anticavity, antigingivitis, antisensitivity toothpaste

Description

Drug Facts

Uses
  • aids in the prevention of cavities
  • helps prevent gingivitis
  • helps interfere with the harmful effects of plaque associated with gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Section 42229-5

Drug Facts

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 sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care.

Section 50567-7

When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist.

Purposes

Anticavity, antigingivitis, antisensitivity toothpaste

Directions
  • adults and children 12 yrs. & 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) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
  • do not swallow
  • children under 12 yrs.: ask a dentist
Questions?

1-800-594-4158

Active Ingredient

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

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 Crest is specially formulated to help prevent staining
  • see your dentist regularly
Inactive Ingredients

water, sorbitol, hydrated silica, sodium lauryl sulfate, carrageenan, sodium gluconate, flavor, sodium hydroxide, zinc citrate, xanthan gum, cocamidopropyl betaine, stannous chloride, sodium saccharin, sucralose, titanium dioxide

Principal Display Panel 116 G Tube Carton

Crest ®

PRO-HEALTH

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

Gentle Whitening

ALL DAY PROTECTION*

Starts working on

sensitivity immediately**

for relief within days.

SOFT MINT

NET WT 4.1 OZ (116 g)


Structured Label Content

Uses
  • aids in the prevention of cavities
  • helps prevent gingivitis
  • helps interfere with the harmful effects of plaque associated with gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Section 42229-5 (42229-5)

Drug Facts

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 sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care.

Section 50567-7 (50567-7)

When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist.

Purposes

Anticavity, antigingivitis, antisensitivity toothpaste

Directions
  • adults and children 12 yrs. & 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) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
  • do not swallow
  • children under 12 yrs.: ask a dentist
Questions?

1-800-594-4158

Active Ingredient (Active ingredient)

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Other Information (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 Crest is specially formulated to help prevent staining
  • see your dentist regularly
Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, sodium lauryl sulfate, carrageenan, sodium gluconate, flavor, sodium hydroxide, zinc citrate, xanthan gum, cocamidopropyl betaine, stannous chloride, sodium saccharin, sucralose, titanium dioxide

Principal Display Panel 116 G Tube Carton (PRINCIPAL DISPLAY PANEL - 116 g Tube Carton)

Crest ®

PRO-HEALTH

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

Gentle Whitening

ALL DAY PROTECTION*

Starts working on

sensitivity immediately**

for relief within days.

SOFT MINT

NET WT 4.1 OZ (116 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)