Label: SODIUM FLUORIDE- clear mint, gel toothpaste gel

  • NDC Code(s): 67777-180-01, 67777-180-02, 67777-180-03, 67777-180-04, view more
    67777-180-05, 67777-180-06, 67777-180-07, 67777-180-08, 67777-180-09, 67777-180-10, 67777-180-11
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 27, 2024

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  • Active Ingredient

    Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use(s)

    Helps protect against cavities

  • Warnings

    If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

    Keep Out of Reach of Children

    Keep out of reach of children under 6 years of age

  • Directions

    • Adults and children 2 years of age and older: Brush teeth thoroughtly after meals or at least twice a day or use as directed by a dentist or physician.

    • Children under 6 years: To minimize swallowing, use a pea sized amount and supervise child's brushing and rinsing until good habits are established.

    • Children under 2 years: Ask a dentist or physician.

  • Inactive Ingredients

    Carboxymethylcellulose Sodium, Hydrated Silica, Peppermint Oil, Polyethylene Glycol 1450, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol

  • Other Information

    Store between 15º-35ºC (59º-95ºF)

  • Questions?

    1-888-396-2739 Monday - Friday 9AM - 5PM EST

  • Label 5900

    5900_BX_MASTER5900 Clear Mint, Gel Toothpaste

  • Label 5901

    5901_BX_MASTER5901 Clear Mint, Gel Toothpaste

  • Label 5902

    5902_IN_MASTER5902 Clear Mint, Gel Toothpaste

  • Label 5903

    5903_BX_MASTER5903 Clear Mint, Gel Toothpaste

  • INGREDIENTS AND APPEARANCE
    SODIUM FLUORIDE 
    clear mint, gel toothpaste gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-180
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-180-03720 in 1 CASE07/16/2024
    1NDC:67777-180-02144 in 1 BOX
    1NDC:67777-180-0117 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:67777-180-0660 in 1 CASE07/16/2024
    2NDC:67777-180-051 in 1 BOX
    2NDC:67777-180-04130 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:67777-180-08144 in 1 CASE07/16/2024
    3NDC:67777-180-0742.5 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:67777-180-11720 in 1 CASE07/16/2024
    4NDC:67777-180-10144 in 1 BOX
    4NDC:67777-180-0924 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02107/16/2024
    Labeler - Dynarex Corporation (008124539)
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