Burkhart neutral gel

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 section

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

Inactive ingredients:

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

Ingredients and appearance - Product information

Burkhart neutral gel- Sodium fluoride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 43498-301
Route of Administration Dental

Active Ingredient/Active Moiety

Ingredient Name Strength
Sodium fluoride ( UNII: 8ZYQ1474W7)( Fluoride ion - UNII: Q80VPU408O ) 0.597 gin 120 g

Inactive Ingredients

Ingredient Name Code
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

Flavor CHERRY Color white (opaque)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - Burkhart Dental Supply Inc( 027532357)

Package label.principal display panel

Package label.principal display panel