Ionite H
Ionite H is an FDA drug label for the active ingredient STANNOUS FLUORIDE manufactured by Dharma Research, Inc. administered by DENTAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231011.
- Generic name
- STANNOUS FLUORIDE
- Manufacturer
- Dharma Research, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- DENTAL
- Dosage form
- N/A
- NDC
- 53045-271
- Application
- M021
- Label effective
- 20231011
Active ingredients
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
Contraindications
Not available.
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.
Adverse Reactions
Not available.