Active Ingredient
Cetylpyridinium Chloride 0.05%
Gurunanda Anti-gingivitis Rinse
FDA Label NDC 70708-012
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-gingivitis (NDC 70708-012). 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, stop use and ask a dentist if, keep out of reach of children under 6 years of age., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigingivitis/Antiplaque
Uses
- Helps prevent gingivitis, an early form of gum disease, and bleeding gums
- Helps control plaque that leads to gingivitis and bleeding gums
Warnings
Warnings
Stop Use And Ask A Dentist If
- Gingivitis, bleeding, or redness persists for more than 2 weeks
- You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontits, a serious form of gum disease
Keep Out Of Reach Of Children Under 6 Years Of Age.
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: Vigorously swish 20 mL (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
Children 6 years to under 12 years: Supervise use.
Children under 6 years of age: Do not use.
Other Information
- Do not use if printed safety seal on the bottle's neck is broken or missing
- Recommended storage temperature 59°F-77°F (15°C-25°C)
Inactive Ingredients
Citric Acid, Disodium Phosphate, Glycerin, Lemon Oil, Poloxamer 407, Spearmint Oil, Stevia Leaf Extract, Water
Package Label.Principal Display Panel
08883.16 (08883.16)
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