CREST BLUE BUBBLE GUM

Main information

  • Trade name:
  • CREST BLUE BUBBLE GUM- 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 BLUE BUBBLE GUM- 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:
  • 37000-495-42
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

CREST BLUE BUBBLE GUM- 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.

----------

Crest

Blue Bubble Gum

Drug Facts

Active ingredient

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

Purpos e

Anticavity toothpaste

Us e

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

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, flavor, sodium phosphate,

cellulose gum, carbomer, sodium saccharin, blue 1

Questions?

1-800-492-7378

Dist. by Procter & Gamble,

Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 119 g pump label

FIGHTS CAVITIES

Crest®

®

FLUORIDE ANTICAVITY TOOTHPASTE

BLUE BUBBLE GUM

STAR

WARS™

GENTLE ON ENAMEL

STRENGTHENS ENAMEL

NET WT 4.2 OZ (119 g)

CREST BLUE BUBBLE GUM

sodium fluoride paste, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:370 0 0 -49 5

Route of Administration

DENTAL

Procter & Gamble Manufacturing Company

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

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

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

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

WATER (UNII: 0 59 QF0 KO0 R)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM PHO SPHATE (UNII: SE337SVY37)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

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

Product Characteristics

Color

blue

S core

S hap e

S iz e

Flavor

BUBBLE GUM

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:370 0 0 -49 5-

119 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 1/20 17

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 8 /0 1/20 0 8

Labeler -

Procter & Gamble Manufacturing Company (004238200)

Revised: 11/2017