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Just For Kids (3M ESPE Dental Products)

Available Formats

Dosage Form Package Information Links
GEL 1 BOTTLE, PLASTIC in 1 BOX (48878-4020-3) > 121.9 g in 1 BOTTLE, PLASTIC Label Information

Complete Just For Kids Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    Stannous fluoride 0.4% w/w (0.12% w/v fluoride ion)


  • Purpose

    Anticavity


  • Use

    Aids in the prevention of dental decay


  • Warnings

    • This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
    • Keep out of reach of children. If more than used for brushing is accidentally swallowed, gel 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.

  • Directions

    • Adults and children 6 years of age and older: Use a pea-sized (.25g) dose 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

    • Do not freeze or expose to extreme heat.
    • Do not use if tamper evident seal on top of box is broken or removed.

  • Inactive ingredients

    ascorbic acid, carbomer, citric acid, flavor, glycerin, triethanolamine


  • Questions or comments?

    call toll free M-F 9am to 5pm EST/EDT at 1-800-634-2249


  • PRINCIPAL DISPLAY PANEL

    Grapey Grape

    NDC 48878-4020-3

    3M ESPE

    Just For Kidsâ„¢

    0.4% Stannous Fluoride

    Preventive Treatment Gel

    IMPORTANT: Read

    directions thoroughly.

    Contents:

    NET WT. 4.3 oz (121.9 g)

    Principal Display Panel

  • PRINCIPAL DISPLAY PANEL

    Bubble Gum

    NDC 48878-4070-3

    3M ESPE

    Just For Kidsâ„¢

    0.4% Stannous Fluoride

    Preventive Treatment Gel

    IMPORTANT: Read

    directions thoroughly.

    Contents:

    NET WT. 4.3 oz (121.9 g)

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    JUST FOR KIDS 
    stannous fluoride gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:48878-4020
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    stannous fluoride (UNII: 3FTR44B32Q) (fluoride ion - UNII:Q80VPU408O) fluoride ion 0.969 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ascorbic acid (UNII: PQ6CK8PD0R)  
    carbomer homopolymer type b (allyl sucrose crosslinked) (UNII: Z135WT9208)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    glycerin (UNII: PDC6A3C0OX)  
    trolamine (UNII: 9O3K93S3TK)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE (GRAPE) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:48878-4020-3 1 in 1 BOX 07/01/1997
    1 121.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 07/01/1997
    JUST FOR KIDS 
    stannous fluoride gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:48878-4070
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    stannous fluoride (UNII: 3FTR44B32Q) (fluoride ion - UNII:Q80VPU408O) fluoride ion 0.969 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ascorbic acid (UNII: PQ6CK8PD0R)  
    carbomer homopolymer type b (allyl sucrose crosslinked) (UNII: Z135WT9208)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    glycerin (UNII: PDC6A3C0OX)  
    trolamine (UNII: 9O3K93S3TK)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BUBBLE GUM (BUBBLE GUM) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:48878-4070-3 1 in 1 BOX 07/01/1997
    1 121.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 07/01/1997
    Labeler - 3M ESPE Dental Products (801390852)