Label: SENSIBLE- sodium lauryl sulfate 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 July 11, 2014

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  • ACTIVE INGREDIENT

    sodium lauryl sulfate


  • INACTIVE INGREDIENT

    water, glycerin, allantoin, ethanol, polyoxyethylene hydrogenated castor oil, l-menthol, xylitol, steviol glycoside, citric acid, moutan root bark ext, erythritol, sodium citrate, blue no 1 1/250, ascorbic acid


  • PURPOSE

    dental care


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    - Adults and children 2 yrs. and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Do not swallow
    - Children under 6 yrs: To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established
    - Children under 2 yrs: Ask a dentist or physician


  • WARNINGS

    do not swallow


  • DOSAGE & ADMINISTRATION

    dental care only

  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    SENSIBLE  
    sodium lauryl sulfate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69086-1001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) (LAURYL SULFATE - UNII:DIQ16UC154) SODIUM LAURYL SULFATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69086-1001-10.08 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/11/2014
    Labeler - Guardian Angel of Preventive Dentistry (688150332)
    Registrant - Guardian Angel of Preventive Dentistry (688150332)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Angel of Preventive Dentistry688150332manufacture(69086-1001)
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