CREST 3D WHITE WHITENING PLUS THERAPY- sodium fluoride 
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 ®
3D White™

Whitening + Therapy

Drug Facts

Active ingredient

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

Purposes

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, sodium lauryl sulfate, flavor, trisodium phosphate, cellulose gum, sodium phosphate, sodium saccharin, carbomer.

Questions?

1-800-492-7378

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - Kit Carton

Crest ®

3D WHITE™

NO SLIP

WHITESTRIPS™

DENTAL WHITENING KIT | FLUORIDE ANTI-CAVITY TOOTHPASTE

WHITENING + THERAPY

6 YEARS OF STAIN REMOVAL | STRENGHTHENS ENAMEL

28 STRIPS: 14 TREATMENTS (EACH WITH 1 UPPER/1LOWER); 1TUBE 0.85 OZ (24g) FLUORIDE ANTICAVITY TOOTHPASTE

411

CREST 3D WHITE  WHITENING PLUS THERAPY
sodium fluoride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-411
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-411-011 in 1 CARTON; Type 1: Convenience Kit of Co-Package01/23/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 24 g
Part 214 PACKET 28 
Part 1 of 2
CREST 3D WHITE  ENAMEL STRENGTHENING SERUM
sodium fluoride paste, dentifrice
Product Information
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
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
124 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/23/2018
Part 2 of 2
CREST 3D WHITE  NO SLIP WHITESTRIPS
other oral hygiene products strip
Product Information
Route of AdministrationDENTAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRBUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
INGRWATER (UNII: 059QF0KO0R)  
INGRPOVIDONE (UNII: FZ989GH94E)  
INGRHYDROGEN PEROXIDE (UNII: BBX060AN9V)  
INGRPOLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic07/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/23/201806/19/2021
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2019
Document Id: 8bb32c45-a021-066f-e053-2a95a90ad3d4
Set id: 63751e77-51c9-37f0-e053-2991aa0a30e3
Version: 4
Effective Time: 20190619
 
The Procter & Gamble Manufacturing Company