Label: BAIRD GOOD NIGHT- sodium fluoride, sodium monofluorophosphate paste, dentifrice

  • 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 March 17, 2021

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  • active ingredient

    Sodium Monofluorophosphate (0.74%)

  • Keep out of reach of children under 6 years of age.

    If more than what is used for brushing is swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right

    away.

  • Purpose

    Helps protect against cavities

  • Uses

    Helps protect against cavities

  • Warnings

    Stop use and ask a doctor if you experience any problems in your gums, mouth, or teeth.

  • Directions

    Adults and children 2 years of age and older

    Brush tooth thoroughly, preferably after each meal, or at least

    twice a day, or as directed by your dentist. Do not swallow.

    Children 2 to 6 years

    To minimize swallowing, use a pea-sized amount and

    supervising brushing until good habits are established.

    Children under 2 years

    Ask a dentist or physician

  • Inactive Ingredients

    Sorbitol, water, hydrated silica, sodium pca, glycerin, sodium methylcocoytaurate,

    tetrasodium pyrophosphate, cellulose gum, flavor, scutellaria baicalensis root extract,

    propolis extract, mentha piperita (peppermint) oil, tocopherylacetate, glucosylstevioside,

    xylitol, menthol, pyridoxine hcl, anthemis nobilis flower extract, camellia sinensis leaf extract,

    Rosmarinus officinalis (rosemary) leaf extract, salvia officinalis (sage) leaf extract, ascorbic

    acid, ecklonia cava extract, commiphora myrrha resin extract, krameria triandra root extract,

    chamomilla recutita (matricaria) flower extract

  • Other Information

    Store at room temperature

  • Baird Good Night Toothpaste

    Baird Good Night Toothpaste

  • INGREDIENTS AND APPEARANCE
    BAIRD GOOD NIGHT 
    sodium fluoride, sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81239-100
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.74 g  in 100 g
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0976 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81239-100-021 in 1 CARTON12/03/2020
    1NDC:81239-100-01100 g in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/03/2020
    Labeler - JK INSPIR Co., Ltd (694700174)
    Registrant - JK INSPIR Co., Ltd (694700174)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kumho Dental Pharmaceutical Co., Ltd631133766manufacture(81239-100)
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