Label: ONETOOTHCLINIC TOOTH- silicon dioxide, tocopherol acetate, sodium pyrophosphate paste
- NDC Code(s): 73527-0001-1
- Packager: CONE MEDICAL Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 30, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
- Do not swallow and rinse mouth thoroughly after use
- If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor.
- For children under 6 years of age, use small amounts of toothpaste. And
- use itunder the supervision of a guardian to avoid sucking or swallowing.
- Consult a physician or dentist immediately if a child under 6 years old
- hasswallowed large quantities.
- Keep out of the reach of children under 6 years of age.
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ONETOOTHCLINIC TOOTH
silicon dioxide, tocopherol acetate, sodium pyrophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73527-0001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE 0.5 g in 100 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 14 g in 100 g ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73527-0001-1 100 g in 1 TUBE; Type 0: Not a Combination Product 11/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/14/2019 Labeler - CONE MEDICAL Co., Ltd. (695811691) Registrant - CONE MEDICAL Co., Ltd. (695811691) Establishment Name Address ID/FEI Business Operations HealingStory.,LTD. 688403124 manufacture(73527-0001) Establishment Name Address ID/FEI Business Operations CONE MEDICAL Co., Ltd. 695811691 label(73527-0001)
