Label: GEL-KAM MINT- stannous fluoride gel, dentifrice
GEL-KAM FRUIT AND BERRY- stannous fluoride gel, dentifrice

  • NDC Code(s): 0126-0165-93, 0126-0192-93
  • Packager: Colgate Oral Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 9, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Stannous fluoride 0.4% (w/w)

  • Purposes

    Anticavity/Sensitivity Relief

  • Uses

    • helps protect against cavities
    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • Warnings

    Do not use this product longer than four weeks for sensitive teeth unless recommended by a dentist or physician.

    Stop use and ask a doctor if problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age or older: use after regular brushing and flossing
    • shake excess water from your toothbrush and cover bristles with gel
    • brush thoroughly
    • keep on your teeth for one minute and then spit out
    • do not swallow
    • do not rinse, eat or drink for 30 minutes
    • use once a day for cavity protection
    • use twice a day (morning and evening) for sensitivity relief or as recommended by a dentist or physician
    • make sure all sensitive areas are covered by using a toothbrush or a cotton swab
    • supervise children until capable of using without supervision
    • children under 12 years of age: consult a dentist or physician
  • Other information

    • this is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before use
    • 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
    • do not use if embossed seal on tube is broken or missing
    • to open tube, remove cap and pierce foil seal with point of cap
    • keep tightly closed when not in use
    • store at controlled room temperature 68-77°F (20-25°C)
  • Inactive ingredients

    flavor, glycerin, hydroxyethylcellulose

  • Questions or comments?

    call toll free at 1-800-962-2345

  • PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Mint

    NDC 0126-0192-93

    Colgate®

    Gel•Kam®

    0.4% Stable Stannous Fluoride
    PREVENTATIVE TREATMENT GEL
    For Cavity Protection and Sensitive Teeth
    MINT

    NET WT 4.3 OZ (122 g)

    PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Mint
  • PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Fruit and Berry

    NDC 0126-0165-93

    Colgate®

    Gel•Kam®

    0.4% Stable Stannous Fluoride
    PREVENTATIVE TREATMENT GEL
    For Cavity Protection and Sensitive Teeth
    FRUIT & BERRY

    NET WT 4.3 OZ (122 g)

    PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Fruit and Berry
  • INGREDIENTS AND APPEARANCE
    GEL-KAM MINT 
    stannous fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0126-0192
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0126-0192-931 in 1 CARTON01/01/1990
    1122 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35501/01/1990
    GEL-KAM FRUIT AND BERRY 
    stannous fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0126-0165
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0126-0165-931 in 1 CARTON01/01/1990
    1122 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35501/01/1990
    Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)