emmi dent Sodium Fluoride Anticavity Mild description, usages, side effects, indications, overdosage, supplying and lots more!

emmi dent Sodium Fluoride Anticavity Mild

EMAG AG
EMAG AG

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
emmi dent Sodium Fluoride Anticavity Toothpaste

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

emmi dent Sodium Fluoride Anticavity Toothpaste Mild


Active Ingredient

Sodium fluoride 0.243% (0.16 w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

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

  • Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits  (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years: Consult a dentist or doctor.

Inactive Ingredients

water, hydrated silica, sorbitol, propylene glycol, tetrapotassium pyrophosphate, xanthan, gum, sodium C14-16 olefin sulfonate, flavor, titanium dioxide, sodium methylparaben, sodium saccharin, allantoin, limonene, chamomile (chamomilla recutita) flower extract, three-lobe sage (salvia triloba) leaf extract, citral

Representative Labeling

Representative LabelingRepresentative Labeling

emmi dent Sodium Fluoride Anticavity Mild

SODIUM FLUORIDE PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63956-001
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.16 g

Inactive Ingredients

Ingredient Name Strength
water
HYDRATED SILICA
sorbitol
propylene glycol
POTASSIUM PYROPHOSPHATE
XANTHAN GUM
SODIUM C14-16 OLEFIN SULFONATE
titanium dioxide
METHYLPARABEN SODIUM
saccharin sodium
ALLANTOIN
LIMONEN-10-OL, (+)-
CHAMOMILE
THREE-LOBE SAGE
CITRAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 90.6 in 1 TUBE
2 NDC:63956-001-90 1 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2014-04-22


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