Label: PERFECT CHOICE- sodium fluoride and hydrofluoric acid gel
- NDC Code(s): 0273-7006-16
- Packager: Young Dental Manufacturing Co 1, LLC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
Updated September 30, 2015
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- Indications and Usage:
Topical application of APF gel is indicated in the prevention of dental caries.Close
Keep out of reach of children. Do not swallow.
If swallowed during treatment, administer milk, limewater, or antacid. If larger dose is ingested (more than 1/4 ounce), contact poison control and immediately seek medical help.Close
For professional use only. Repeated use may cause dulling of porcelain and ceramic restorations.Close
- Adverse reactions:
Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. Individuals hypersensitive to fluoride may have an adverse reaction.Close
- Dosage and Administration:
After thorough prophylaxis, place gel in applicator tray (not more than 1/3 full). Throughly air-dry teeth and insert tray(s) in mouth. Gel may also be swab applied. Instruct patient to bite down slightly but firmly for one to four minutes. A slight chewing motion enhances coverage interproximally. Remove tray(s) and have patient expectorate excess gel. Instruct patient not to eat, drink or rinse for at least 30 minutes.Close
- How Supplied:
A gel, one bottle contains up to 68 individual applications. Store at controlled room temperature 20°- 25°C (68°-77°F).
Do not allow to freeze.Close
1.23% w/w Fluoride Ion (0.79% from Sodium Fluoride and 0.44% from Hydrogen Fluoride) in 0.1 Molar Phosphoric Acid
Contains: FD&C Red #40
Reorder NO. APF 205PS
TIME TO REORDER! CALL YOUR DENTAL DEALER.
Earth City, MO 63045
Questions or Comments?
12000235A Rev 12/2006Close
- Principal Display Panel
APF Topical Gel
60 Second Treatment
Acidulated Phosphate Fluoride
1.23% Fluroide Ion
Net Weight: 17.5 oz. (497g)
- INGREDIENTS AND APPEARANCE
sodium fluoride and hydrofluoric acid gel
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-7006 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 7.9 mg in 1 g HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 4.4 mg in 1 g Product Characteristics Color Score Shape Size Flavor PEPPERMINT (Peppermint Stick) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0273-7006-16 497 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/31/2006 Labeler - Young Dental Manufacturing Co 1, LLC. (006309355) Registrant - Young Dental Manufacturing Co 1, LLC. (006309355) Establishment Name Address ID/FEI Business Operations Medical Products Laboratories, Inc. 002290302 manufacture(0273-7006)