Label: CREST PRO-HEALTH COMPLETE PROTECTION BACTERIA SHIELD- stannous fluoride paste, dentifrice
- NDC Code(s): 69423-916-40, 69423-916-85
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated June 4, 2021
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- Drug Facts
- 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.
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.
- 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
- KEEP OUT OF REACH OF CHILDREN
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
Principal Display Panel - 113 g tube in carton
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*
*Protects against plaque bacteria that lead to gingivitis with twice daily brushing
INGREDIENTS AND APPEARANCE
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 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg in 1 g Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) STANNOUS CHLORIDE (UNII: 1BQV3749L5) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) CARRAGEENAN (UNII: 5C69YCD2YJ) SODIUM GLUCONATE (UNII: R6Q3791S76) XANTHAN GUM (UNII: TTV12P4NEE) ZINC CITRATE (UNII: K72I3DEX9B) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SORBITOL (UNII: 506T60A25R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-916-40 1 in 1 CARTON 01/22/2021 1 113 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69423-916-85 1 in 1 CARTON 01/22/2021 2 24 g in 1 TUBE; Type 0: Not a Combination Product 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)