Ionite H .63 mg/100mL

Stannous Fluoride · MOUTHWASH · Dharma Research, Inc.

No Recall History

Plain English

Ionite H is a mouthwash containing stannous fluoride at .63 mg/100mL, taken dental. Manufactured by Dharma Research, Inc..

Key Facts

Brand Name: Ionite H
Generic Name: Stannous Fluoride
NDC Code (Product): 53045-276
Manufacturer: Dharma Research, Inc.
Strength: .63 mg/100mL
Dosage Form: MOUTHWASH
Route: DENTAL
Marketing Status
Application #: M021
Marketing Start: 08/03/2015

Recall History

No Recall History

Side Effects Reported to FDA

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

oral discomfort5 reports

dyspnoea4 reports

nausea4 reports

oral disorder4 reports

oral pain4 reports

anaemia3 reports

diarrhoea3 reports

fatigue3 reports

gingival discomfort3 reports

off label use3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Aids in the prevention of dental cavities (caries).

Dosage & Administration

Directions • This is not a toothpaste. Read directions carefully before using. • Adults and children 6 years of age and older: o Use once per day after brushing teeth thoroughly with toothpaste o Twist off cap to remove foil seal o Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces. o Allow the gel to remain on your teeth for 1 minute o Spit out. Do not swallow o Do not eat, drink, or rinse for at least 30 minutes • Children under 6: consult a dentist or doctors

Warnings

Warnings Keep out of reach of children. If more that used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not swallow. Supervision of children is required when using this product. Developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.

Frequently Asked Questions

What is Ionite H used for?

Ionite H contains Stannous Fluoride. It is a mouthwash taken dental. Consult your doctor for specific uses.

Is Ionite H a controlled substance?

Ionite H is not classified as a controlled substance by the DEA.

What is the generic name for Ionite H?

The generic name for Ionite H is Stannous Fluoride. There are 12 other brand versions of Stannous Fluoride.

What is the NDC code for Ionite H .63 mg/100mL?

The NDC (National Drug Code) for Ionite H .63 mg/100mL is 53045-276, listed by Dharma Research, Inc..

Product NDC

53045-276

Package NDC

53045-276-10

Other Stannous 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)