CREST GUM DETOXIFY

Main information

  • Trade name:
  • CREST GUM DETOXIFY- stannous fluoride paste, dentifrice
  • Composition:
  • FLUORIDE ION 1.4 mg in 1 g
  • Administration route:
  • DENTAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CREST GUM DETOXIFY- stannous fluoride paste, dentifrice
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Anticavity, antigingivitis toothpaste - aids in the prevention of cavities - helps prevent gingivitis - helps interfere with the harmful effects of plaque associated with gingivitis - helps control plaque bacteria that contribute to the development of gingivitis

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 37000-481-01, 37000-481-41
  • Last update:
  • 01-06-2019

Summary of Product characteristics: dosage, interactions, side effects

CREST GUM DETOXIFY- stannous 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®

Gum Detoxify ®

Drug Facts

Active ingredient

Stannous fluoride 0.454%

(0.14% w/v fluoride ion)

Purpos es

Anticavity, antigingivitis toothpaste

Us es

aids in the prevention of cavities

helps prevent gingivitis

helps interfere with the harmful effects of plaque associated with gingivitis

helps control plaque bacteria that contribute to the development of gingivitis

Warning

Keep out of reach of children under 12 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 12 yrs. of age and older: Brush teeth thoroughly, preferably after each meal or at

least twice a day, or as directed by a dentist or physician.

do not swallow

children under 12 yrs. of age: ask a dentist

Other information

products containing stannous fluoride may produce surface staining of the teeth

adequate toothbrushing may prevent these stains which are not harmful or permanent and may be

removed by your dentist

this Crest is specially formulated to help prevent staining

see your dentist regularly

Inactive ingredients

water, sorbitol, hydrated silica, sodium lauryl sulfate, carrageenan, sodium gluconate, flavor, xanthan

gum, zinc citrate, stannous chloride, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide

Ques tions ?

1-800-594-4158

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Principal Display Panel - 24 g tube in carton

Crest®

Gum

Detoxify®

FLUORIDE TOOTHPASTE FOR

ANTICAVITY AND ANTIGINGIVITIS

Neutralizes plaque bacteria,

even around the gum line

DEEP CLEAN

NET WT 0.85 OZ (24 g)

CREST GUM DETOXIFY

stannous fluoride paste, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:370 0 0 -48 1

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

STANNO US FLUO RIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

FLUORIDE ION

1.4 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

STANNO US CHLO RIDE (UNII: 1BQV3749 L5)

WATER (UNII: 0 59 QF0 KO0 R)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

CARRAGEENAN (UNII: 5C6 9 YCD2YJ)

SO DIUM GLUCO NATE (UNII: R6 Q379 1S76 )

XANTHAN GUM (UNII: TTV12P4NEE)

ZINC CITRATE (UNII: K72I3DEX9 B)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

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

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

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

SPEARMINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:370 0 0 -48 1-0 1

1 in 1 CARTON

0 8 /0 1/20 17

1

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

2

NDC:370 0 0 -48 1-41

1 in 1 CARTON

0 1/29 /20 18

2

116 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 8 /0 1/20 17

The Procter & Gamble Manufacturing Company

Labeler -

T he Procter & Gamble Manufacturing Company (004238200)

Revised: 1/2018