Label: FLUORIDE GEL- sodium fluoride 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 January 6, 2018

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  • Active ingredients

    Sodium Fluoride 0.22%(0.15 w/v Fluoride ion)

    Purpose

    anticavity

  • Uses

    helps protect against cavities.

  • Warnings

    Keep out of the 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 immediately.

    Keep out of reach of children.

  • Directions

    Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.

    Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

    Children under 2 years:Ask a dentist or a physician.

  • INACTIVE INGREDIENT

    Sorbitol,Silica,methyl Paraben Sodium,Propyl Paraben Sodium ,Flavour ,Sodium Saccharin,Treated Water,SCMC,Sodium Lauryl Sulfate

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    FLUORIDE GEL 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71035-400
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOCYSTEINE LYSINE MONOHYDRATE (UNII: QA5ZP9OL3E)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYL PARAOXON (UNII: UE1A2XL95H)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71035-400-01720 in 1 BOX05/25/2016
    117 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71035-400-02720 in 1 BOX05/25/2016
    224 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:71035-400-03144 in 1 BOX03/07/2016
    343 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:71035-400-041000 in 1 BOX05/01/2015
    40.22 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:71035-400-051000 in 1 BOX05/01/2015
    57 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 finalpart35605/01/2015
    Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
    Registrant - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou Hongshengding Chemical Co.,Ltd.543774755manufacture(71035-400)
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