Label: TEND ANTICAVITY- sodium monofluorophosphate gel
- NDC Code(s): 78594-000-01, 78594-000-02
- Packager: Tend, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 June 22, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
- Warnings
-
Directions
- Adults and children 6 years of age and older: our dentists recommend applying a pea-sized dollop of toothpaste on a soft-bristled toothbrush. Brush teeth thoroughly for 2 minutes twice a day, and not more than 3 times a day, or as recommended by your dentist or hysician. Minimize swallowing.
- Children under 6 years of age: consult a dentist or physician.
- Inactive ingredients
- QUESTIONS
- Package Labeling:
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
TEND ANTICAVITY
sodium monofluorophosphate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78594-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.3 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CALCIUM CARBONATE (UNII: H0G9379FGK) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78594-000-01 1 in 1 CARTON 01/01/2022 1 96 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:78594-000-02 0.8 g in 1 TUBE; Type 1: Convenience Kit of Co-Package 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/2022 Labeler - Tend, LLC (117113952)