Label: GELATO NEUTRAL PH- sodium fluoride gel
- NDC Code(s): 68400-136-15
- Packager: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
- Category: HUMAN PRESCRIPTION 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.
Updated November 19, 2013
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- Active Ingredient:
Sodium Fluoride 2%Close
Fluoride treatment gel.Close
- Indications and Usage:
- 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 consumer use.
- 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.
- Dosage and Administration:
Shake well before use. This is a 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 prophylaxis, 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 four minutes.
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.Close
- Other Infomation:
Store at controlled room temperature 59° to 86°F (15°-30°C).
Protect from freezing.Close
- Inactive Ingredients:
Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.Close
- INGREDIENTS AND APPEARANCE
GELATO NEUTRAL PH
sodium fluoride gel
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68400-136 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 4.086 g in 454 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PHOSPHORIC ACID (UNII: E4GA8884NN) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color white (Dye Free) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68400-136-15 454 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/01/2013 Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (078654194) Establishment Name Address ID/FEI Business Operations Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc 078654194 manufacture(68400-136) , label(68400-136)