Indications And Usage:
Topical application of APF gel is indicated in the prevention of dental caries.
Perfect Choice
FDA Label NDC 0273-7006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Young Dental Manufacturing Co 1, Llc. for the product Perfect Choice (NDC 0273-7006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications and usage:, warning:, precautions:, adverse reactions:, dosage and administration:, how supplied:, active ingredients:, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warning:
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. Do not use on patients with an allergy to fluoride.
Precautions:
For professional use only. This product is not intended for home or unsupervised consumer use. Repeated use may cause dulling of porcelain and ceramic restorations.
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.
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.
How Supplied:
A thixotropic 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.
Active Ingredients:
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
Principal Display Panel
NDC 0273-7006-16
ZOOBY®
PERFECT CHOICE®
1.23% APF TOPICAL GEL
STRIPED
PEPPERMINT
STICK
60-Second
Treatment Acidulated
Phosphate Fluoride
1.23% Fluoride Ion
Net Weight: 17.5 oz. (497g)
Apf_peppermint (4543)
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