CREST PRO-HEALTH FOR ME- sodium 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.

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Crest ® Pro-Health For Me™

Drug Facts

Active ingredient

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warning

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

  • 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, disodium pyrophosphate, sodium lauryl sulfate, sodium hydroxide, flavor, sodium saccharin, xanthan gum, carbomer, polyethylene, mica, titanium dioxide, blue 1 lake

Questions?

1-800-594-4158

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 164 g Tube Carton

Crest®

PRO-HEALTH
FOR ME ™

FLUORIDE ANTICAVITY TOOTHPASTE
MINTY BREEZE
✩ STRENGTHENS ENAMEL ✩ FIGHTS CAVITIES

NET WT 5.8 OZ (164 g)

STAR
WARS ™

FOR LONGER
BRUSHING

Disney
MAGIC TIMER™

Disney MARVEL

UNLOCK EVEN MORE CHARACTERS
AS YOU BRUSH

PRINCIPAL DISPLAY PANEL - 164 g Tube Carton
CREST PRO-HEALTH FOR ME 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-861
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
Product Characteristics
Colorwhite (Clear gel w/blue specks) Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-861-041 in 1 CARTON01/15/201512/01/2018
1119 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:37000-861-051 in 1 CARTON01/15/201512/01/2018
2164 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/15/201512/01/2018
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2016
Document Id: 441acd88-a0f8-544b-e054-00144ff88e88
Set id: c8e6d8da-4b08-4df2-a50b-31818e0849e0
Version: 5
Effective Time: 20161220
 
The Procter & Gamble Manufacturing Company