EXODEN ALL IN ONE- silicon dioxide, tetrasodium pyrophosphate, sodium monofluorophosphate, sodium fluoride paste

EXODEN ALL IN ONE by

Drug Labeling and Warnings

EXODEN ALL IN ONE by is a Otc medication manufactured, distributed, or labeled by LIFEON Corp., Korea Shidenta. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Silicon dioxide 10%

Tetrasodium Pyrophosphate 3.40%

Sodium Monofluorophosphate 0.38%

sodium fluoride 0.11%

PURPOSE

Anti plaque

Anti tartar

Anti cavity

INDICATIONS & USAGE

Aids in cleanness of teeth and protection of gum health

DOSAGE & ADMINISTRATION

Supervise children as necessary until capable of using without supervision

Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician

Children under 12 years: Instruct in good brushing and rinsing habits (to minimize swallowing)

Children under 6 years: Do not use unless directed by a dentist or a physician

WARNINGS

Ask a dentist before use if you have
bleeding or redness lasting more than 2 weeks
pain, swelling, pus, loose teeth, or more spacing between teeth
These may be signs of periodontitis, a serious form of gum disease

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

Bentonite, Sorbitol, Glycerin, Stevioside, Xylitol, Cellulose Gum, Sodium Cocoyl Glutamate, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Salvia Officinalis (Sage) Leaf Extract, Zingiber Officinale (Ginger) Rhizome Extract, Eucalyptus Globulus Leaf Oil, Menthol, Mentha Piperita (Peppermint) Oil, Chamaecyparis Obtusa Oil, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXODEN ALL IN ONE 
silicon dioxide, tetrasodium pyrophosphate, sodium monofluorophosphate, sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70602-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ)	SODIUM PYROPHOSPHATE	3.4 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	10 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.38 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.11 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
STEVIOSIDE (UNII: 0YON5MXJ9P)
XYLITOL (UNII: VCQ006KQ1E)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ROSEMARY (UNII: IJ67X351P9)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
SAGE (UNII: 065C5D077J)
GINGER (UNII: C5529G5JPQ)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70602-010-02	1 in 1 CARTON	07/13/2022
1	NDC: 70602-010-01	100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/13/2022

Labeler - LIFEON Corp. (688528872)

Registrant - LIFEON Corp. (688528872)

Establishment
Name	Address	ID/FEI	Business Operations
Korea Shidenta		688171734	manufacture(70602-010)