Label: NEUTRAGEL- sodium fluoride gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 3, 2017

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

View All Sections
  • Recommended use:

    A topical anticaries preparation for dental use only.

  • PURPOSE

    1.1% Neutral sodium fluoride gel for topical fluoride gel treatments. Neutragel provides 0.5% fluoride ion from sodium fluoride in a neutral (pH7), unflavored, unsweetened, stabilized gel base. The special formulation is non-etching on porcelain or ceramic filled restorations. Ideal for chemotherapy and Zerostomia patients.

  • Medicinal ingredient:

    0.5% fluoride ion (from 1.1% sodium fluoride)

  • Non-medicinal ingredients:

    Purified water, glycerin carboxymethylcellulose sodium, sodium benzoate, sodium citrate, and citric acid anhydrous.

  • Directions:

    1. Fill Germiphene brand disposable Gel Trays. After thorough prophylaxis, air dry teeth and insert trays for four minutes. 2. Remove trays and excess gel.

  • Warning/Caution:

    Do not eat, drink, or rinse for 30 minutes after treatment. Do not use if tamper-evident foil seal is broken. Do not store in direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    227 g450 g

  • INGREDIENTS AND APPEARANCE
    NEUTRAGEL 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0370
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 2.6 g  in 100 g
    WATER (UNII: 059QF0KO0R) 86.1 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 10 g  in 100 g
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.12 g  in 100 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.007 g  in 100 g
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.093 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61508-0370-1120 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/2017
    2NDC:61508-0370-2450 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/06/2017
    Labeler - Germiphene Corporation (206412512)
    Establishment
    NameAddressID/FEIBusiness Operations
    Germiphene Corporation206412512manufacture(61508-0370)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!