Label: EXODEN ALL IN ONE- silicon dioxide, tetrasodium pyrophosphate, sodium monofluorophosphate, sodium fluoride paste
- NDC Code(s): 70602-010-01, 70602-010-02
- Packager: LIFEON Corp.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated July 13, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Supervise children as necessary until capable of using without supervisionAdults 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
- KEEP OUT OF REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
EXODEN ALL IN ONE
silicon dioxide, tetrasodium pyrophosphate, sodium monofluorophosphate, sodium fluoride pasteProduct 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)
