Crest®

Crest®
SPL v10
SPL
SPL Set ID 575c6610-2e8b-2a2f-e053-2991aa0a9819
Route
DENTAL
Published
Effective Date 2016-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.4 mg)
Inactive Ingredients
D&c Yellow No. 10 Sucralose Stannous Chloride Water Hydrated Silica Carrageenan Sodium Gluconate Xanthan Gum Zinc Citrate Sodium Lauryl Sulfate Sorbitol Sodium Hydroxide Saccharin Sodium Fd&c Green No. 3 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-06-17

Description

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

Purpose

Anticavity, antigingivitis, antisensitivity toothpaste


Medication Information

Purpose

Anticavity, antigingivitis, antisensitivity toothpaste

Description

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

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

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Purposes

Anticavity, antigingivitis, antisensitivity toothpaste

Warnings

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

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.

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.

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
Drug Facts

Active ingredient

Stannous fluoride 0.454%

(0.14% w/v fluoride ion)

Questions?

1-800-594-4158

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, xanthan gum, zinc citrate, stannous

chloride, sodium hydroxide, sodium saccharin, sucralose, green 3, yellow 10, yellow 6

Principal Display Panel: 130g Tube in Carton

Crest ® PRO-HEALTH

WITH A TOUCH OF

scope®





FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH





CAVITIES | GINGIVITIS | ACID EROSION+ | SENSITIVITY PLAQUE | TARTAR | WHITENING | FRESHENS BREATH







NET WT 4.6 OZ (130g)


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)

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Purposes

Anticavity, antigingivitis, antisensitivity toothpaste

Warnings

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

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.

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.

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
Drug Facts

Active ingredient

Stannous fluoride 0.454%

(0.14% w/v fluoride ion)

Questions?

1-800-594-4158

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, xanthan gum, zinc citrate, stannous

chloride, sodium hydroxide, sodium saccharin, sucralose, green 3, yellow 10, yellow 6

Principal Display Panel: 130g Tube in Carton (Principal display panel: 130g tube in carton)

Crest ® PRO-HEALTH

WITH A TOUCH OF

scope®





FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH





CAVITIES | GINGIVITIS | ACID EROSION+ | SENSITIVITY PLAQUE | TARTAR | WHITENING | FRESHENS BREATH







NET WT 4.6 OZ (130g)


Advanced Ingredient Data


Raw Label Data

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