Active Ingredient
Sodium Fluoride 0.05% (0.2 w/v fluoride ion)
Gurunanda Anti-cavity Rinse
FDA Label NDC 70708-890
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gurunanda, Llc for the product Gurunanda Anti-cavity (NDC 70708-890). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Uses
Aids in the prevention of dental cavities
Warnings
Warnings
Keep Out Of Reach Of Children
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
Adults and children 12 years of age and older:
- Use once a day after brushing your teeth with a toothpaste.
- Vigorously swish 10 mL of rinse between your teeth for 1 minute and then spit out.
- Do not swallow the rinse.
- Do not eat or drink for 30 minutes after rinsing.
- Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
- Supervise children as necessary until they are capable of using without supervison.
- Consult a dentist or doctor
Children under 6 years of age:
Other Information
- Do not use if printed seal is broken or missing
- Recommended storage temperature 59°F-77°F (15°C-25°C)
Inactive Ingredients
Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Sodium Bicarbonate, Disodium Phosphate, Sodium Chlorite, Menthol, Stevia Leaf Extract, Flavor, Disodium EDTA, Xylitol, Citric Acid
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