Label: GELATO APF- sodium fluoride gel
- NDC Code(s): 68400-106-15
- 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 April 22, 2015
If you are a consumer or patient please visit this version.
- Active ingredient: Purpose:
Fluoride Ion 1.23% ............................... Fluoride Treatment Gel
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.Close
- Indications and usage:
- A stable thixtropic fluoride treatment gel used to help prevent dental decay.
- For professional office 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 quantites 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 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 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 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.Close
- Other information:
- Store at controlled room temperature 59° to 86°F (15° -30°C). Protect from freezing.
- 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 (tartrazine), yellow #6 as a color additive.Close
- INGREDIENTS AND APPEARANCE
sodium fluoride gel
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68400-106 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 5.6 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) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Water (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) XYLITOL (UNII: VCQ006KQ1E) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain FD&C BLUE NO. 1 (UNII: H3R47K3TBD) May contain FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) May contain FD&C RED NO. 3 (UNII: PN2ZH5LOQY) May contain FD&C RED NO. 40 (UNII: WZB9127XOA) May contain FD&C YELLOW NO. 5 (UNII: I753WB2F1M) May contain FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68400-106-15 454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/14/2012 Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301) Establishment Name Address ID/FEI Business Operations Keystone Industries 014769301 manufacture(68400-106) , label(68400-106)