CREST 3D WHITE GLAMOROUS WHITE- 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 ® 3D White™

Glamorous White

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

  • 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

water, sorbitol, hydrated silica, disodium pyrophosphate, xylitol, flavor, sodium hydroxide, cellulose gum, cocamidopropyl betaine, sodium laureth-2 phosphate, sodium saccharin, xanthan gum, carbomer, sucralose, polyethylene oxide, polyethylene, mica, titanium dioxide, blue 1 lake

Questions?

1-800-959-6586

Dist. by Procter & Gamble, Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

NEW

Crest

3D WHITE
FLOURIDE ANTICAVITY
TOOTHPASTE

GLAMOROUS
WHITE

SHINES TO
BRIGHTEN IN
JUST 1 DAY

REMOVES UP
TO 90% OF
SURFACE STAINS
IN 5 DAYS

ENAMEL SAFE
WHITENING

VIBRANT
MINT

P&G
WORLDWIDE PARTNER

NET WT
4.1 OZ
(116 g)

Principal Display Panel
CREST 3D WHITE  GLAMOROUS WHITE
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-831
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
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
Colorwhite (with blue gel stripe) Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-831-011 in 1 CARTON02/20/201203/22/2015
124 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:37000-831-041 in 1 CARTON02/20/201203/22/2015
2116 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:37000-831-051 in 1 CARTON02/20/201203/22/2015
3164 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/20/201203/22/2015
Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 10/2016
Document Id: 3f113700-02a3-2219-e054-00144ff88e88
Set id: eaed97cd-33c0-4d21-93b3-989b2776e49d
Version: 2
Effective Time: 20161017
 
Procter & Gamble Manufacturing Company