Label: AMERFRESH TOOTH- sodium monofluorophosphate powder
-
Contains inactivated NDC Code(s)
NDC Code(s): 70766-005-01, 70766-005-02 - Packager: Yangzhou SION Commodity Co.,Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 18, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Uses
- Warnings
-
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
-
INGREDIENTS AND APPEARANCE
AMERFRESH TOOTH
sodium monofluorophosphate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70766-005 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (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:70766-005-01 40 in 1 CARTON 04/20/2018 1 454 g in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:70766-005-02 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 not final part356 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(70766-005)
