BURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]

BURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]
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NDC 43498-251-04
Set ID 6d8078e9-b0d8-4220-b90a-3f14fa0e43f4
Category HUMAN OTC DRUG LABEL
Packager Burkhart Dental Supply Inc
Generic Name
Product Class
Product Number
Application Number PART355
  • Active Ingredient:

    Stannous Fluoride 0.4%

  • Purpose:

    Fluoride preventive treatment gel.

  • Uses:

    • Home Care is a stable, water-free fluoride gel for home use.
    • Aids in the prevention of dental decay.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Warnings:

    • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
    • This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
    • This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
  • Directions:

    Adults and children 6 years of age and older: Twist off cap and remove foil seal. Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: consult a dentist or doctor.

  • Other Information:

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

  • Inactive Ingredients:

    Carbopol, Flavor, Glycerine, Malic Acid, Sodium Carboxymethylcellulose, Water, Xanthan Gum.

  • PRINCIPAL DISPLAY PANEL

    SC.Burkhart .40 Stannous_berry.jpgSC.Burkhart .40 Stannous_berry.jpg

  • PRINCIPAL DISPLAY PANEL

    BX.Burkhart .40 Stannous.jpgBX.Burkhart .40 Stannous.jpg

  • INGREDIENTS AND APPEARANCE
    BURKHART 
    stannous fluoride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43498-251
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.116 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Malic Acid (UNII: 817L1N4CKP)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorwhite (Cloudy) Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43498-251-04120 g in 1 TUBE; Type 0: Not a Combination Product09/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/05/2013
    Labeler - Burkhart Dental Supply Inc (027532357)

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