Label: ADVANCED WHITENING ANTI CAVITY FLUORIDE- sodium fluoride paste

  • 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 June 21, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient

    Sodium Fluoride (0.15% w/v fluoride ion)

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Uses

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

    Warning

  • WHEN USING

    When using this product

    • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.
  • STOP USE

    Stop and ask a dentist

    • if the problem persists or worsens.

    Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • If accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately.
  • DOSAGE & ADMINISTRATION

    Directions

    Adults and Children 12 years of age and older:

    • apply at least a 1-inch strip of product onto soft bristle toothbrush
    • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times 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.

  • SPL UNCLASSIFIED SECTION

    Other information

    • store in a cool, dry place.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    calcium carbonate, FD&C blue#1, flavor, methylparaben, poly ethylene glycol 400, propylparaben, sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium saccharin, sodium silicate, sorbitol, precipited silica, tetra sodium pyrophosphate, titanium dioxide, water.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    ADVANCED WHITENING ANTI-CAVITY FLUORIDE TOOTHPASTE

    label

  • INGREDIENTS AND APPEARANCE
    ADVANCED WHITENING ANTI CAVITY FLUORIDE 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-035
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-035-461 in 1 BOX06/21/2017
    1181 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/21/2017
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Universal Distribution Center LLC (019180459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou Holyshine Industrial Co. Ltd421141948manufacture(52000-035)
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