CREST 3D WHITE BRILLIANCE

Main information

  • Trade name:
  • CREST 3D WHITE BRILLIANCE- sodium fluoride paste, dentifrice
  • Composition:
  • FLUORIDE ION 1.6 mg in 1 g
  • Administration route:
  • DENTAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CREST 3D WHITE BRILLIANCE- sodium fluoride paste, dentifrice
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Anticavity toothpaste helps protect against cavities

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 37000-873-01, 37000-873-04, 37000-873-08, 37000-873-12
  • Last update:
  • 01-06-2019

Summary of Product characteristics: dosage, interactions, side effects

CREST 3D WHITE BRILLIANCE- 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

3D White™

Brilliance

Drug Facts

Active ingredient

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

Purpos e

Anticavity toothpaste

Us e

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

glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, trisodium phosphate,

sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, PEG-20M or PEG-23M,

xanthan gum, sucralose, mica, titanium dioxide

Ques tions ?

1-800-492-7378

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 24 g Tube Carton

®

®

Crest

3D WHITE™

FLUORIDE ANTICAVITY

TOOTHPASTE

DISSOLVING POLISHING COMPLEX

NET WT 0.85 OZ (24 g)

OUR FASTEST WHITENING TECHNOLOGY

+

OUR MOST ADVANCED STAIN PROTECTION

BRILLIANCE

WITH 3X STAIN-FIGHTING POWER*

ENAMEL SAFE WHITENING

VIBRANT PEPPERMINT

CREST 3D WHITE BRILLIANCE

sodium fluoride paste, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:370 0 0 -8 73

Route of Administration

DENTAL

®

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

FLUORIDE ION

1.6 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

SO DIUM PO LYMETAPHO SPHATE (UNII: P1BM4ZH9 5L)

WATER (UNII: 0 59 QF0 KO0 R)

PO LYETHYLENE GLYCO L 3 0 0 (UNII: 56 55G9 Y8 AQ)

SO DIUM PHO SPHATE, TRIBASIC, ANHYDRO US (UNII: SX0 1TZO3QZ)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

CARRAGEENAN (UNII: 5C6 9 YCD2YJ)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

PO LYETHYLENE O XIDE 9 0 0 0 0 0 (UNII: 16 P9 29 5IIL)

PO LYETHYLENE O XIDE 10 0 0 0 0 0 (UNII: HZ58 M6 D8 39 )

XANTHAN GUM (UNII: TTV12P4NEE)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

MICA (UNII: V8 A1AW0 8 8 0 )

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

PEPPERMINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:370 0 0 -8 73-0 4

1 in 1 CARTON

0 7/0 6 /20 15

1

116 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:370 0 0 -8 73-0 8

2 in 1 CELLO PACK

0 7/0 6 /20 15

2

1 in 1 CARTON

2

116 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:370 0 0 -8 73-12

3 in 1 CELLO PACK

0 7/0 6 /20 15

3

1 in 1 CARTON

3

116 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:370 0 0 -8 73-0 1

1 in 1 CARTON

0 7/0 6 /20 15

4

24 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

The Procter & Gamble Manufacturing Company

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 7/0 6 /20 15

Labeler -

T he Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2018