Label: DR. SHEFFIELD SENSITIVE CARE- sensitive tooth paste paste, dentifrice

  • NDC Code(s): 11527-420-45
  • Packager: Sheffield Pharmaceuticals LLC
  • 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 April 21, 2020

If you are a consumer or patient please visit this version.

  • Drug Fact

  • Active Ingredient

    Potassium Nitrate 5%

  • Purpose

    Tooth desensitizer

  • Uses

    Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

  • Warnings 

    When using this product, if pain/sensivity still persists after 4 weeks of use, please ask your dentist.

    Stop Use and ask a Dentist, if the problem persists or worsens, Sensitive teeth may indicate a serious problem that may neeed prompt care of a dentist. 

    When using this product, if pain/sensivity still persists after 4 weeks of use, stop use and contact your dentist.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of Children, If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and older: Apply at least a 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. 
    Make sure to brush all sensitive areas of the teeth.
    Children under 12 years of age: consult a dentist or doctor.

  • Inactive ingredients

    Dicalcium Phosphate Dihydrate, Water (purified), Glycerin, Calcium Carbonate, Organic Cocos Nucifera (Coconut) oil, Quillaja Saponaria Wood Extract, Organic Aloe Barbadensis Leaf, Xylitol, Carrageenan, Xanthum Gum, Stevia Rebaudiana Leaf/Stem Extract, Yucca Schidigera Root extract, Quillaja Saponaria Bark Extract, Smilax Aristolochiaefolia Root extract, Dioscorea Villosa (Wild Yam) Root extract, Natural Peppermint flavor, Natural Menthol, Natural Spearmint Flavor, Natural Fennel Flavor, Iris Florentina (Orris) Root Powder, Propolis Extract, Organic Melaleuca Alternifolia(teatree) oil, Commiphora Myrrha (Myrrha) ResinExtract, Sodium Benzoate

  • Questions? Call 1-800-222-1087

  • Principal Primary Panel Tube 5.0 oz

    Dr Sheffield Certified Natural Toothpaste Sensitive Tube.jpg

    Dr. Sheffield Certifed Natural Toothpaste

    Sensitive Care Natural Mint

    NET WT. 5 OZ (141g)

    Dr Sheffield Certified Natural Toothpaste Sensitive Tube.jpg

  • Principal Primary Panel Carton 5.0 oz

    Dr Sheffield Certified Natural Toothpaste Sensitive carton.jpg

    Dr. Sheffield Certifed Natural Tooth Paste 

    Sensitive Care Natural Mint Flavor

    NET WT. 5 oz ( 141g)

    Dr Sheffield Certified Natural Toothpaste Sensitive carton.jpg

    Dr Sheffield Certified Natural Toothpaste Sensitive carton.jpg

  • INGREDIENTS AND APPEARANCE
    DR. SHEFFIELD SENSITIVE CARE 
    sensitive tooth paste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-420
    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
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    QUILLAJA SAPONARIA WOOD (UNII: 1L8K0593B6)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
    DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8)  
    IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    COMMIPHORA MYRRHA TOP (UNII: N534J96ODY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-420-451 in 1 CARTON05/15/2017
    1141 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 finalpart35605/15/2017
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(11527-420)