Label: AMERFRESH TOOTH- sodium fluoride powder
- NDC Code(s): 70766-004-01, 70766-004-02
- Packager: Yangzhou SION Commodity Co.,Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 16, 2024
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- Official Label (Printer Friendly)
- Active ingredients
- Uses
- Warnings
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Directions
For Use:
- Wet toothbrush and dip into powder until brush is fully covered
- do not swallow .
- supervise children as necessary until capable of useing without supervision
- instruct children under 12 years of age in good brushing and rinsing habits(to minimize swallowing).
- 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 6 years of age:do not use unless directed by a doctor or dentist.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AMERFRESH TOOTH
sodium fluoride powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70766-004 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) CALCIUM CARBONATE (UNII: H0G9379FGK) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70766-004-01 40 in 1 CARTON 04/20/2018 1 454 g in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:70766-004-02 4 in 1 CARTON 04/20/2018 2 50 in 1 BOX 2 57 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 04/20/2018 Labeler - Yangzhou SION Commodity Co.,Ltd (546806042) Registrant - Yangzhou SION Commodity Co.,Ltd (546806042) Establishment Name Address ID/FEI Business Operations Yangzhou SION Commodity Co.,Ltd 546806042 manufacture(70766-004)
