Label: AMERFRESH- sodium fluoride paste
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NDC Code(s):
70766-002-01,
70766-002-02,
70766-002-03,
70766-002-04, view more70766-002-05, 70766-002-06, 70766-002-07, 70766-002-08, 70766-002-09, 70766-002-10, 70766-002-11, 70766-002-12
- Packager: Yangzhou SION Commodity Co.,Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 8, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Uses
- Warnings
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Directions
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
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70766-002 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.22 g in 100 g Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM (UNII: SB8ZUX40TY) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) DISODIUM CARBOXYMETHYLARSONATE (UNII: T9HTL93NB7) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) METHYLENE GLYCOL (UNII: 6Z20YM9257) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) HYDRATED SILICA (UNII: Y6O7T4G8P9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70766-002-01 144 in 1 BOX 05/25/2016 1 17 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70766-002-02 144 in 1 BOX 05/25/2016 2 24 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:70766-002-03 144 in 1 BOX 05/25/2016 3 43 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:70766-002-04 144 in 1 BOX 05/25/2016 4 78 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:70766-002-05 144 in 1 BOX 06/18/2016 5 85 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:70766-002-06 144 in 1 BOX 06/18/2016 6 142 g in 1 TUBE; Type 0: Not a Combination Product 7 NDC:70766-002-07 1000 in 1 BOX 06/18/2016 7 7 g in 1 BAG; Type 0: Not a Combination Product 8 NDC:70766-002-10 1000 in 1 BOX 06/18/2016 8 7.1 g in 1 BAG; Type 0: Not a Combination Product 9 NDC:70766-002-08 5 in 1 CARTON 11/29/2016 9 144 in 1 BOX 9 17 g in 1 TUBE; Type 0: Not a Combination Product 10 NDC:70766-002-09 5 in 1 CARTON 11/29/2016 10 144 in 1 BOX 10 24 g in 1 TUBE; Type 0: Not a Combination Product 11 NDC:70766-002-11 72 in 1 BOX 06/18/2016 11 142 g in 1 TUBE; Type 0: Not a Combination Product 12 NDC:70766-002-12 72 in 1 BOX 06/18/2016 12 181 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 OTC Monograph Drug M021 03/01/2016 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(70766-002)
