Label: GOODSENSE SENSITIVE EXTRA WHITENING- potassium nitrate, and sodium fluroide paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 12, 2017

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  • ACTIVE INGREDIENT

    Active ingredients                                                               Purpose

    Potassium nitrate 5%........................................ Antihypersensitivity

    Sodium fluoride 0.15% w/v fluoride ion..............................Anticavity

  • PURPOSE

    Uses

    • builds increasing protection against painful sensitivity of the teeth due to cold, heat, acids, sweets or contact
    • aids in the prevention of dental cavities
  • WARNINGS

    Warnings

    Stop use and ask a dentist if

    • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may prompt care by a dentist
    • pain/sensitivty still persists after 4 weeks of use
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • adults and children 12 years of age and older
    • appy at least 1-inch strip of product onto a soft bristle toothbrush
    • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
    • children under 12 years of age: consult a dentist or doctor
  • STORAGE AND HANDLING

    Other information

    • store below 30°C (86°F)
    • Lot No. & Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients sorbitol, water, hydrated silica, cocamidopropyl betaine, PEG 1500, flavor, cellulose gum, titanium dioxide, sodium saccharin, menthol, tetrasodium pyrophosphate

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Geiss, Destin & Dunn, Inc.

    Peachtree City, GA 30269

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    GOODSENSE SENSITIVE EXTRA WHITENING 
    potassium nitrate, and sodium fluroide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-780
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-780-041 in 1 BOX12/29/2015
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/29/2015
    Labeler - Geiss, Destin & Dunn, Inc. (076059836)
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