MENTADENT ADVANCED BREATH FRESHENING

Main information

  • Trade name:
  • MENTADENT ADVANCED BREATH FRESHENING- sodium fluoride paste, dentifrice
  • Composition:
  • SODIUM FLUORIDE 2.4 mg in 1 g
  • Administration route:
  • DENTAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MENTADENT ADVANCED BREATH FRESHENING- sodium fluoride paste, dentifrice
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Purpose Anticavity toothpaste Use  aids in the prevention of dental decay

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 10237-616-10
  • Last update:
  • 29-05-2019

Summary of Product characteristics: dosage, interactions, side effects

MENTADENT ADVANCED BREATH FRESHENING- sodium fluoride paste, dentifrice

Church & Dwight Co., Inc.

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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DRUG FACTS

Active ingredients

Sodium fluoride (0.24%)

Purpose

Anticavity toothpaste

Use aids in the prevention of dental decay

Warnings

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control

Center right away.

Directions supervise children as necessary until capable of using without supervision

do not swallow

adults and children 2 years and older brush teeth thoroughly after meals or at least twice a

day, or use as directed by a dentist or physician

children under 6 years instruct in good brushing and rinsing habits (to

minimize swallowing)

children under 2 years ask a dentist or physician

Inactive ingredients water, glycerin, sorbitol, hydrated silica, poloxamer 407, sodium bicarbonate,

PEG-32, sodium lauryl sulfate, SD alcohol 38-B, zinc citrate trihydrate, flavor, hydrogen peroxide,

cellulose gum, sodium saccharin, phosphoric acid, blue 1, titanium dioxide

Questions or comments? Call 1-800-786-5135 Monday-Friday 9am-5pm ET

Principal Display Panel

MENTADENT

Anticavity Fluoride Toothpaste

Baking Soda and Peroxide

Advanced Breath Freshening

Mint Sparkle

with MICROBEADS and WHITENING CRYSTALS

NET WT. 5.25 OZ. (148.8g) EACH

TOTAL WT. 10.5 OZ. (297.6g) EACH

Carton image

MENTADENT ADVANCED BREATH FRESHENING

sodium fluoride paste, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 237-6 16

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)

SODIUM FLUORIDE

2.4 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

PEG-3 2 STEARATE (UNII: 33GX5WQC0 M)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

ZINC CITRATE (UNII: K72I3DEX9 B)

HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V)

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

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

Church & Dwight Co., Inc.

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PHO SPHO RIC ACID (UNII: E4GA8 8 8 4NN)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

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

Product Characteristics

Color

blue, white

S core

S hap e

S iz e

Flavor

MINT (Mint Sparkle)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 237-6 16 -10

1 in 1 CARTON

1

148 .8 g in 1 CARTRIDGE

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 4/0 1/20 0 4

Labeler -

Church & Dwight Co., Inc. (001211952)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Church & Dwight Co ., Inc.

0 436 9 0 8 12

ma nufa c ture

Revised: 11/2010