OTC Medication Information: Crest Pro-Health Complete Protection Bacteria Shield

CREST PRO-HEALTH COMPLETE PROTECTION BACTERIA SHIELD- stannous fluoride paste, dentifrice
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Stannous fluoride 0.454%

(0.14% w/v fluoride ion)

Purposes

Anticavity, antigingivitis, antisensitivity toothpaste

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.

Warning

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 under 12 yrs. of age. 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. 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

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

Questions?

1-800-492-7378

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Principal Display Panel — 113 g tube in carton

Crest ®

PRO-HEALTH™

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

NET WT 4.0 OZ (113 g)

CAVITIES GINGIVITIS ACID EROSION** SENSITIVITY PLAQUE TARTAR WHITENING FRESHENS BREATH

ANTI-BAC 24 HOUR PROTECTION*

COMPLETE PROTECTION

BACTERIA SHIELD

*Protects against plaque bacteria that lead to gingivitis with twice daily brushing

69423916
(click image for full-size original)
CREST PRO-HEALTH COMPLETE PROTECTION BACTERIA SHIELD
stannous fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-916
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.4 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SUCRALOSE
STANNOUS CHLORIDE
WATER
HYDRATED SILICA
CARRAGEENAN
SODIUM GLUCONATE
XANTHAN GUM
ZINC CITRATE
SODIUM LAURYL SULFATE
SORBITOL
SODIUM HYDROXIDE
SACCHARIN SODIUM
TITANIUM DIOXIDE
Product Characteristics
Color white Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69423-916-40 1 TUBE in 1 CARTON contains a TUBE
1 113 g in 1 TUBE This package is contained within the CARTON (69423-916-40)
2 NDC:69423-916-85 1 TUBE in 1 CARTON contains a TUBE
2 24 g in 1 TUBE This package is contained within the CARTON (69423-916-85)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 01/22/2021
Labeler — The Procter & Gamble Manufacturing Company (004238200)

Revised: 06/2021 The Procter & Gamble Manufacturing Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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