Drugplain

PureLife APF 5.6 g/454g

Sodium Fluoride · GEL · PureLife Dental

No Recall HistoryCurrently in Shortage
Plain English

PureLife APF is a gel containing sodium fluoride at 5.6 g/454g, taken dental. Manufactured by PureLife Dental.

Key Facts

Brand Name
PureLife APF
Generic Name
Sodium Fluoride
NDC Code (Product)
68987-012
Manufacturer
PureLife Dental
Strength
5.6 g/454g
Dosage Form
GEL
Route
DENTAL
Marketing Status
Marketing Start
12/18/2012

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pyrexia170 reports
fatigue159 reports
nausea158 reports
vomiting156 reports
pain154 reports
weight increased154 reports
nasopharyngitis152 reports
type 2 diabetes mellitus145 reports
peripheral swelling144 reports
urticaria143 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Indications and Usage A stable thixotropic 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.

Dosage & Administration

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 twice 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.

Warnings

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.

Frequently Asked Questions

What is PureLife APF used for?

PureLife APF contains Sodium Fluoride. It is a gel taken dental. Consult your doctor for specific uses.

Is PureLife APF a controlled substance?

PureLife APF is not classified as a controlled substance by the DEA.

What is the generic name for PureLife APF?

The generic name for PureLife APF is Sodium Fluoride. There are 12 other brand versions of Sodium Fluoride.

What is the NDC code for PureLife APF 5.6 g/454g?

The NDC (National Drug Code) for PureLife APF 5.6 g/454g is 68987-012, listed by PureLife Dental.

Product NDC

68987-012

Package NDC

68987-012-15

Other Sodium Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)