crest pro-health advanced enamel restore

crest pro-health advanced enamel restore
SPL v6
SPL
SPL Set ID d813f5f0-3135-4a8f-e053-2a95a90a5562
Route
dental
Published
Effective Date 2022-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.6 mg)
Inactive Ingredients
povidone, unspecified fd&c blue no. 1 zinc lactate glycerin cocamidopropyl betaine sodium polymetaphosphate propylene glycol polyethylene glycol 300 sodium gluconate water hydrated silica carrageenan xanthan gum sodium lauryl sulfate saccharin sodium sodium phosphate, tribasic, anhydrous

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
otc monograph drug active Since 2022-01-01

Purpose

Anticavity, antigingivitis, antisensitivity toothpaste

Description

Active ingredient Stannous fluoride 0.454% (0.16% w/v fluoride ion)


Medication Information

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
Purpose

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. of age: ask a dentist
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

glycerin, hydrated silica, sodium hexametaphosphate, propylene glycol, PEG-6, water, zinc lactate, flavor, sodium lauryl sulfate, sodium gluconate, sodium saccharin, trisodium phosphate, xanthan gum, PVP, carrageenan, cocamidopropyl betaine, blue 1

Description

Active ingredient Stannous fluoride 0.454% (0.16% w/v fluoride ion)

Questions?

1-800-594-4158

Section 42229-5

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

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

Drug Facts

Active ingredient

Stannous fluoride 0.454%

(0.16% w/v fluoride ion)

Principal Display Panel 144 G Tube in Carton

Crest ®

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

CAVITIES GINGIVITIS ENAMEL SENSITIVITY PLAQUE TARTAR WHITENING FRESHENS BREATH

NET WT 5.1 OZ (144 g)

DENTIST DESIGNED

CLINICALLY PROVEN*

PRO HEALTH™

ADVANCED

HELPS PREVENT PLAQUE GROWTH TO STOP ISSUES BEFORE THEY START.**

ENAMEL RESTORE


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
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. of age: ask a dentist
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)

glycerin, hydrated silica, sodium hexametaphosphate, propylene glycol, PEG-6, water, zinc lactate, flavor, sodium lauryl sulfate, sodium gluconate, sodium saccharin, trisodium phosphate, xanthan gum, PVP, carrageenan, cocamidopropyl betaine, blue 1

Questions?

1-800-594-4158

Section 42229-5 (42229-5)

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

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

Drug Facts

Active ingredient

Stannous fluoride 0.454%

(0.16% w/v fluoride ion)

Principal Display Panel 144 G Tube in Carton (Principal Display Panel - 144 g tube in carton)

Crest ®

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

CAVITIES GINGIVITIS ENAMEL SENSITIVITY PLAQUE TARTAR WHITENING FRESHENS BREATH

NET WT 5.1 OZ (144 g)

DENTIST DESIGNED

CLINICALLY PROVEN*

PRO HEALTH™

ADVANCED

HELPS PREVENT PLAQUE GROWTH TO STOP ISSUES BEFORE THEY START.**

ENAMEL RESTORE


Advanced Ingredient Data


Raw Label Data

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