Drugplain

Pronamel Repair Whitening 5 g/100g

Fluoride · PASTE, DENTIFRICE · Rite Aid

No Recall History
Plain English

Pronamel Repair Whitening is a fluoride toothpaste that helps repair acid-damaged tooth enamel while gently whitening your teeth. This over-the-counter product is designed for daily use to protect and strengthen weakened enamel.

Key Facts

Brand Name
Pronamel Repair Whitening
Generic Name
Fluoride
NDC Code (Product)
11822-6310
Manufacturer
Rite Aid
Strength
5 g/100g
Dosage Form
PASTE, DENTIFRICE
Route
DENTAL
Marketing Status
Application #
M022
Marketing Start
12/01/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

toxicity to various agents16 reports
completed suicide14 reports
drug ineffective10 reports
fatigue10 reports
headache10 reports
nausea10 reports
asthenia9 reports
diarrhoea8 reports
hypersensitivity8 reports
arthralgia7 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact * aids in the prevention of dental cavities

Dosage & Administration

adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush * brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.*children under 12 years of age: Consult a dentist or doctor.

Warnings

When using this product, of iffitation occurs discontine use. Stop use and ask a dentist if the problem persists or worsen. Sensitive teeth may indicate a serious problem that many need prompt care by a dentist.* pain/sensitivty still persists after 4 weeks of use.

Frequently Asked Questions

What is Pronamel Repair Whitening used for?

Pronamel Repair Whitening is a fluoride toothpaste that helps repair acid-damaged tooth enamel while gently whitening your teeth. This over-the-counter product is designed for daily use to protect and strengthen weakened enamel.

Is Pronamel Repair Whitening a controlled substance?

Pronamel Repair Whitening is not classified as a controlled substance by the DEA.

What is the generic name for Pronamel Repair Whitening?

The generic name for Pronamel Repair Whitening is Fluoride. There are 12 other brand versions of Fluoride.

What is the NDC code for Pronamel Repair Whitening 5 g/100g?

The NDC (National Drug Code) for Pronamel Repair Whitening 5 g/100g is 11822-6310, listed by Rite Aid.

Product NDC

11822-6310

Package NDC

11822-6310-1

Other Fluoride 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)