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.

----------

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

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

  • 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

Dist. by Procter & Gamble, Cincinnati, OH 45202
www.crest.com

PRINCIPAL DISPLAY PANEL - 170 g Carton

new

Crest

PRO-HEALTH
FOR ME

NET WT 6.0 OZ (170g)

FLUORIDE ANTICAVITY TOOTHPASTE

Designed for
KIDS
8 & Up

FIGHTS CAVITIES
& TARTAR

STRENGTHENS
ENAMEL

FRESHENS BREATH

WHITENS

MINTY BREEZE

Principal Display Panel - 170 g Carton
CREST PRO-HEALTH FOR ME 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-007
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
Colorwhite (Clear w/blue specs) Score    
ShapeSize
FlavorPEPPERMINT, SPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-007-021 in 1 CARTON08/30/201004/20/2017
1NDC:37000-007-0124 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:37000-007-041 in 1 CARTON08/30/201004/20/2017
2119 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:37000-007-061 in 1 CARTON08/30/201004/20/2017
3170 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/30/201004/20/2017
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 11/2016
Document Id: 40cb7088-09cc-011f-e054-00144ff88e88
Set id: fbe1298d-77b1-4866-9883-5d744b184042
Version: 4
Effective Time: 20161108
 
The Procter & Gamble Manufacturing Company