BURKHART NEUTRAL- sodium fluoride gel

Burkhart Neutral by

Drug Labeling and Warnings

Burkhart Neutral by is a Prescription medication manufactured, distributed, or labeled by Burkhart Dental Supply Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

1.1% Sodium Fluoride.

Purpose:

Aids in prevention of dental caries and hypersensitivity. Use as directed by your dentist.

Warnings:

Do not swallow. To avoid ingestion, supervision is required while children are using the product. Keep out of reach of children.

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

Store at controlled room temperature 59° - 86°F (15° - 30°C).

Inactive Ingredients:

Calcium Caseinate, Citric Acid, Flavor, Glycerine, Glydant, Sodium Benzoate, Sodium Hexameta Phosphate, Sodium Saccharine, TriCalcium Phosphate, Vitamin E, Water, Xanthan Gum, Xylitol.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURKHART NEUTRAL 
sodium fluoride gel

Product 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)