CREST 3D WHITE ENAMEL RENEWAL- 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 ® 3D White™

Enamel Renewal

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
FLUORIDE ANTICAVITY
TOOTHPASTE

ENAMEL
RENEWAL

STRENGTHENS &
REBUILDS WEAKENED
ENAMEL

REMOVES UP
TO 90% OF
SURFACE STAINS
IN 7 DAYS

P&G
WORLDWIDE
PARTNER

ENAMEL SAFE
WHITENING

RENEWAL
MINT

NET WT
4.1 OZ
(116 g)

Principal Display Panel - 116 g Tube Carton
CREST 3D WHITE  ENAMEL RENEWAL
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-832
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:37000-832-041 in 1 CARTON02/20/201212/05/2017
1116 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:37000-832-051 in 1 CARTON02/20/201212/05/2017
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 finalpart35502/20/201212/05/2017
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2016
 
The Procter & Gamble Manufacturing Company