- Active Ingredient:
- Purpose:
- Warnings:
-
Directions:
Adults and children 6 years of age and older:
- Twist off cap to remove foil seal.
- Use once daily after brushing teeth thoroughly with toothpaste.
- Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces for at least 1 minute.
- Expectorate, do not swallow, do not eat, drink or rinse for at least 30 minutes.
Children under 6 years of age:
- Consult a dentist or physcian.
- STORAGE AND HANDLING
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BURKHART NEUTRAL
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43498-301 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.597 g in 120 g Inactive Ingredients Ingredient Name Strength CASEIN (UNII: 48268V50D5) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) DMDM HYDANTOIN (UNII: BYR0546TOW) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color white (opaque) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43498-301-04 120 g in 1 TUBE; Type 0: Not a Combination Product 02/11/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/11/2019 Labeler - Burkhart Dental Supply Inc (027532357)