GOODSENSE SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE, AND SODIUM FLUROIDE) PASTE [GEISS, DESTIN & DUNN, INC.]

GOODSENSE SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE, AND SODIUM FLUROIDE) PASTE [GEISS, DESTIN & DUNN, INC.]
PDF | XML

NDC 50804-780-04
Set ID a5634768-18f3-433b-9480-420ccc97d80f
Category HUMAN OTC DRUG LABEL
Packager Geiss, Destin & Dunn, Inc.
Generic Name
Product Class
Product Number
Application Number PART356
  • 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)

Related Drugs