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Home > Drugs > Mouth and throat products > Fluoride topical > 60 Second Fluoride Gel Prescribing Information
Mouth and throat products
https://themeditary.com/pro/60-second-fluoride-gel-prescribing-information-15465.html

60 Second Fluoride Gel Prescribing Information

Drug Detail:Fluoride topical (Fluoride topical [ flor-ide-top-i-kal ])

Drug Class: Mouth and throat products

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Active Ingredient:

Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid

Purpose:

Fluoride Treatment Gel

Indications and Usage for 60 Second Fluoride Gel

  • A stable thixotropic fluoride treatment gel used to help prevent dental decay.
  • For Professional Use Only. This product is not intended for home or unsupervised use.

Warnings

  • Keep out of reach of children.
  • Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
  • Read directions carefully before using.

60 Second Fluoride Gel Dosage and Administration

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Related/similar drugs

fluoride, Prevident, Biotene, Denta 5000 Plus, Prevident 5000 Plus

Storage and Handling

Do not store 25°C/77°F. Do not freeze.

Inactive Ingredients:

Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain Blue #1, Green #3, Red #3, Red #40, Yellow #5 (tartazine). Yellow #6 as a color additive.

60SecFluorideGel_Label.jpg

60 SECOND FLUORIDE GEL
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-2240
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION5.6 g in 454 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHOSPHORIC ACID (UNII: E4GA8884NN)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
ColorredScore
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-2240-1454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/2019
Labeler - Darby Dental Supply, LLC (825137818)

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