CREST CAVITY PROTECTION REGULAR

Main information

  • Trade name:
  • CREST CAVITY PROTECTION REGULAR- 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 CAVITY PROTECTION REGULAR- sodium fluoride paste, dentifrice
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Anticavity toothpaste helps protect teeth and roots against cavities

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 37000-005-01, 37000-005-02, 37000-005-03, 37000-005-04, 37000-005-05, 37000-005-08, 37000-005-09, 37000-005-10, 37000-005-13, 37000-005-20, 37000-005-29
  • Last update:
  • 01-06-2019

Summary of Product characteristics: dosage, interactions, side effects

CREST CAVITY PROTECTION REGULAR- 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.

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Crest

Cavity

Protection

Drug Facts

Active ingredient

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

Purpos e

Anticavity toothpaste

Us e

helps protect teeth and roots 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 956, sodium saccharin, titanium dioxide, blue 1

Ques tions ?

1-800-492-7378

Dist. by Procter & Gamble, Cincinnati OH 45202

www.cres t.com

PRINCIPAL DISPLAY PANEL - 181 g Carton

FIGHTS CAVITIES ON TEETH AND ROOTS

Crest

ADA

ACCEPTED

American

Dental

As s ociation®

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 6.4 OZ (181 g)

CAVITY

PROTECTION

Regular Paste

CREST CAVITY PROTECTION REGULAR

sodium fluoride paste, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:370 0 0 -0 0 5

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

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM PHO SPHATE (UNII: SE337SVY37)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

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

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

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

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

WATER (UNII: 0 59 QF0 KO0 R)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

Product Characteristics

Color

blue

S core

S hap e

S iz e

Flavor

WINTERGREEN

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:370 0 0 -0 0 5-0 1

2.5 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 2/19 8 4

2

NDC:370 0 0 -0 0 5-0 3

1 in 1 CARTON

0 8 /0 2/19 8 4

2

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

3

NDC:370 0 0 -0 0 5-0 4

1 in 1 CARTON

0 8 /0 2/19 8 4

3

18 1 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:370 0 0 -0 0 5-0 5

1 in 1 CARTON

0 8 /0 2/19 8 4

4

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

5

NDC:370 0 0 -0 0 5-10

1 in 1 CARTON

0 8 /0 2/19 8 4

5

NDC:370 0 0 -0 0 5-0 8

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

6

NDC:370 0 0 -0 0 5-0 9

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

0 8 /0 2/19 8 4

0 6 /0 8 /20 18

7

NDC:370 0 0 -0 0 5-13

2 in 1 CARTON

0 8 /0 2/19 8 4

7

18 1 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

8

NDC:370 0 0 -0 0 5-20

3 in 1 CELLO PACK

0 8 /0 2/19 8 4

8

1 in 1 CARTON

8

18 1 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

9

NDC:370 0 0 -0 0 5-0 2

1 in 1 CARTON

0 1/0 1/20 15

9

8 3 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

10

NDC:370 0 0 -0 0 5-29

1 in 1 CARTON

0 8 /0 2/19 8 4

10

8 2 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 2/19 8 4

The Procter & Gamble Manufacturing Company

Labeler -

T he Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2018