Drugplain

AQUAFRESH SENSITIVE MAXIMUM STRENGTH 50 mg/g

potassium nitrate and sodium fluoride · PASTE · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

AQUAFRESH SENSITIVE MAXIMUM STRENGTH is a paste containing potassium nitrate and sodium fluoride at 50 mg/g, taken dental. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
AQUAFRESH SENSITIVE MAXIMUM STRENGTH
Generic Name
potassium nitrate and sodium fluoride
NDC Code (Product)
0135-0605
Manufacturer
Haleon US Holdings LLC
Strength
50 mg/g
Dosage Form
PASTE
Route
DENTAL
Marketing Status
Application #
M022
Marketing Start
02/17/2017

Recall History

No Recall History

Side Effects Reported to FDA

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

drug dependence2 reports
exposure during pregnancy1 reports
lip swelling1 reports
oedema mouth1 reports
oedema mucosal1 reports
oral discomfort1 reports
pharyngeal oedema1 reports
swollen tongue1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions • adults and children 12 years of age and older: o apply at least a 1-inch strip of the product onto a soft bristle toothbrush. o brush teeth thoroughly for at least 1 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

Warnings When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of use. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is AQUAFRESH SENSITIVE MAXIMUM STRENGTH used for?

AQUAFRESH SENSITIVE MAXIMUM STRENGTH contains potassium nitrate and sodium fluoride. It is a paste taken dental. Consult your doctor for specific uses.

Is AQUAFRESH SENSITIVE MAXIMUM STRENGTH a controlled substance?

AQUAFRESH SENSITIVE MAXIMUM STRENGTH is not classified as a controlled substance by the DEA.

What is the generic name for AQUAFRESH SENSITIVE MAXIMUM STRENGTH?

The generic name for AQUAFRESH SENSITIVE MAXIMUM STRENGTH is potassium nitrate and sodium fluoride. There are 12 other brand versions of potassium nitrate and sodium fluoride.

What is the NDC code for AQUAFRESH SENSITIVE MAXIMUM STRENGTH 50 mg/g?

The NDC (National Drug Code) for AQUAFRESH SENSITIVE MAXIMUM STRENGTH 50 mg/g is 0135-0605, listed by Haleon US Holdings LLC.