Label: CREST PRO-HEALTH HEALTHY FRESH- stannous fluoride paste, dentifrice
- NDC Code(s): 37000-841-01, 37000-841-04, 37000-841-06, 37000-841-07
- Packager: 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 April 24, 2015
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Stannous fluoride 0.454% (0.16% w/v fluoride ion)Close
Anticavity, antigingivitis, antisensitivity toothpasteClose
- 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. 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 bristled 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
- 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, trisodium phosphate, flavor, sodium lauryl sulfate, sodium gluconate, carrageenan, sodium saccharin, xanthan gum, polyethylene, blue 1 lake, blue 1Close
- SPL UNCLASSIFIED SECTION
DIST. BY PROCTER & GAMBLE, CINCINNATI, OH 45202Close
- PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
NET WT 6.0 OZ (170 g)
FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH
FIGHTS BAD BREATH
ONE TOOTHPASTE THAT DOES IT ALL:
- FRESHENS BREATH
- INGREDIENTS AND APPEARANCE
CREST PRO-HEALTH HEALTHY FRESH
stannous fluoride paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-841 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 1.6 mg in 1 g Inactive Ingredients Ingredient Name Strength glycerin (UNII: PDC6A3C0OX) hydrated silica (UNII: Y6O7T4G8P9) sodium polymetaphosphate (UNII: P1BM4ZH95L) propylene glycol (UNII: 6DC9Q167V3) polyethylene glycol 300 (UNII: 5655G9Y8AQ) water (UNII: 059QF0KO0R) zinc lactate (UNII: 2GXR25858Y) sodium lauryl sulfate (UNII: 368GB5141J) sodium gluconate (UNII: R6Q3791S76) carrageenan (UNII: 5C69YCD2YJ) saccharin sodium (UNII: SB8ZUX40TY) xanthan gum (UNII: TTV12P4NEE) high density polyethylene (UNII: UG00KM4WR7) FD&C blue no. 1 (UNII: H3R47K3TBD) aluminum oxide (UNII: LMI26O6933) Product Characteristics Color BLUE (with blue specks) Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-841-01 1 in 1 CARTON 1 24 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:37000-841-04 1 in 1 CARTON 2 119 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:37000-841-06 1 in 1 CARTON 3 170 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:37000-841-07 1 in 1 CARTON 4 221 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 02/01/2013 Labeler - Procter & Gamble Manufacturing Company (004238200)