OMNI .969 mg/g
Stannous Fluoride · GEL · Solventum US LLC
OMNI is a gel containing stannous fluoride at .969 mg/g, taken oral. Manufactured by Solventum US LLC.
Key Facts
- Brand Name
- OMNI
- Generic Name
- Stannous Fluoride
- NDC Code (Product)
48878-4061- Manufacturer
- Solventum US LLC
- Strength
- .969 mg/g
- Dosage Form
- GEL
- Route
- ORAL
- Marketing Status
- Application #
- M021
- Marketing Start
- 02/01/1998
Recall History
Wizcure Pharmaa Private Limited
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Wizcure Pharmaa Private Limited
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Wizcure Pharmaa Private Limited
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use Aids in the prevention of dental decay
Dosage & Administration
Directions Adults and children 6 years of age and older: Use a pea-sized (.25g) dose once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.
Warnings
Warnings This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. 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. This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
Frequently Asked Questions
What is OMNI used for?
OMNI contains Stannous Fluoride. It is a gel taken oral. Consult your doctor for specific uses.
Is OMNI a controlled substance?
OMNI is not classified as a controlled substance by the DEA.
What is the generic name for OMNI?
The generic name for OMNI is Stannous Fluoride. There are 12 other brand versions of Stannous Fluoride.
What is the NDC code for OMNI .969 mg/g?
The NDC (National Drug Code) for OMNI .969 mg/g is 48878-4061, listed by Solventum US LLC.
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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)