Label: ANTI CAVITY FLUORIDE- sodium monofluorophosphate 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 Monofluorophosphate  0.76%

    (Total Fluoride Content - 1000 ppm approx.)

  • PURPOSE

    Purpose

    Anticavity toothpaste

  • INDICATIONS & USAGE

    Uses

    • regular brushing with flouride toothpaste helps protect teeth againts 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 under 6 years of age

    • If accidentally swallowed get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children of 6 years and older: brush teeth thoroughly, after meals or at least twice a day, or as directed by a dentist.
    • do not swallow.
    • to minimize swallowing, use pea-sized amount in children under 6 years old.
    • supervise child's brushing until good habits are established.
    • children under 2 years: ask a dentist before use.
  • SPL UNCLASSIFIED SECTION

    Other information

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

    Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    ANTI-CAVITY FLUORIDE TOOTHPASTE

    label

  • INGREDIENTS AND APPEARANCE
    ANTI CAVITY FLUORIDE 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-036
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    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:52000-036-461 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(52000-036)
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