Crest ® Pro-Health ® Stages ®

Drug Labeling and Warnings

Drug Details [pdf]

CREST PRO-HEALTH STAGES- sodium fluoride paste, dentifrice 
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.

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Crest ® Pro-Health ® Stages ®

Drug Facts

Active ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 yrs. of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • twist off cap to remove foil seal
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist

Inactive ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, cellulose gum, flavor, sodium phosphate, sodium saccharin, carbomer, blue 1

Questions?

1-800-285-9139

Dist. by Procter & Gamble,
Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 120 g Tube Label

2+
years

Berry

Disney
JAKE
AND
THE
NEVER LAND
PIRATES

ANTICAVITY FLUORIDE TOOTHPASTE

Crest®

PRO-HEALTH ®
Stages ®

NET WT 4.2 OZ (120 g)

PRINCIPAL DISPLAY PANEL - 120 g Tube Label
CREST PRO-HEALTH STAGES 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37000-675
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PHOSPHATE, TRIBASIC, MONOHYDRATE (UNII: J9O85FKF29)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37000-675-04120 g in 1 TUBE; Type 0: Not a Combination Product08/01/200808/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/01/200808/27/2019
Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 4/2018
 
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