CREST 3D WHITE RADIANT MINT

Main information

  • Trade name:
  • CREST 3D WHITE RADIANT MINT- sodium fluoride paste, dentifrice
  • Composition:
  • FLUORIDE ION 1.5 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 RADIANT MINT- 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:
  • 37000-876-01, 37000-876-02, 37000-876-03, 37000-876-04, 37000-876-05, 37000-876-07, 37000-876-10, 37000-876-12, 37000-876-15, 37000-876-25
  • Last update:
  • 01-06-2019

Summary of Product characteristics: dosage, interactions, side effects

CREST 3D WHITE RADIANT MINT- 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™

Radiant Mint

Drug Facts

Active ingredient

Sodium fluoride 0.243% (0.15% 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

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum,

sodium hydroxide, sodium saccharin, carbomer, mica, titanium dioxide, blue 1

Ques tions ?

1-800-492-7378

DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 99 g Tube Carton

3 BENEFITS IN 1

Crest

®

®

3D WHITE™

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT

3.5 OZ (99 g)

ENAMEL SAFE WHITENING

REMOVES UP TO 80%

OF SURFACE STAINS.

RADIANT MINT

CREST 3D WHITE RADIANT MINT

sodium fluoride paste, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:370 0 0 -8 76

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

1.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

SO DIUM ACID PYRO PHO SPHATE (UNII: H5WVD9 LZUD)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

MICA (UNII: V8 A1AW0 8 8 0 )

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

Product Characteristics

Color

blue

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 76 -0 1

1 in 1 CARTON

0 1/18 /20 16

1

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

2

NDC:370 0 0 -8 76 -0 2

1 in 1 CARTON

0 1/18 /20 16

2

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

3

NDC:370 0 0 -8 76 -0 3

1 in 1 CARTON

0 1/18 /20 16

3

9 9 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:370 0 0 -8 76 -0 4

1 in 1 CARTON

0 1/18 /20 16

4

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

5

NDC:370 0 0 -8 76 -0 5

1 in 1 CARTON

0 2/0 5/20 18

5

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

6

NDC:370 0 0 -8 76 -0 7

2 in 1 CARTON

0 1/18 /20 16

6

9 9 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

7

NDC:370 0 0 -8 76 -10

2 in 1 CARTON

0 1/18 /20 16

7

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

8

NDC:370 0 0 -8 76 -12

1 in 1 CARTON

0 1/18 /20 16

12/31/20 18

8

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

9

NDC:370 0 0 -8 76 -25

5 in 1 CELLO PACK

0 2/0 5/20 18

9

1 in 1 CARTON

9

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

10

NDC:370 0 0 -8 76 -15

3 in 1 CELLO PACK

0 1/18 /20 16

10

1 in 1 CARTON

The Procter & Gamble Manufacturing Company

10

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

Marketing Information

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 1/18 /20 16

Labeler -

T he Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2018