Label: THE HUMBLE CO ANTICAVITY MOUTHWASH FRESH MINT- sodium fluoride rinse

  • NDC Code(s): 72299-011-00
  • Packager: The Humble Company North America Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • Drug Facts

  • Active ingredient

    Sodium fluride 0.05% (0.02% W/V fluoride ion)

    Purpose

    Anticavity

  • Use

    aids in the prevention of dental caries

  • Warning

    Keep out of reach of children.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Adults and children 6 years of age and older:

    Consult a dentist or doctor. Children under 6 years of age:

  • Other information

    Keep the bottle closed and store in a fresh and dry place. Do not use if carton/case is open.

  • Inactive ingredients

    water, glycerin, betaine, polysorbate-80, peppermint (mentha x piperita l.) oil, flavor, rebaudioside A, lycium (lycium barbarum) fruit extract, green tea (camellia sinensis) extract, asian ginseng (panax ginseng) root extract, aloe vera (aloe barbadensis) leaf juice, citric acid, sodium benzoate, potassium sorbate, limonene

  • Package Labeling:

    Bottle2

  • INGREDIENTS AND APPEARANCE
    THE HUMBLE CO ANTICAVITY MOUTHWASH FRESH MINT 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72299-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BETAINE (UNII: 3SCV180C9W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72299-011-00500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02112/01/2019
    Labeler - The Humble Company North America Inc (010966342)
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