Active Ingredient
Cetylpyridinium Chloride 0.1%
Gurunanda Healthy Gums Mouthwash
FDA Label NDC 70708-926
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 Healthy Gums (NDC 70708-926). 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 icnreasing spacing between the teeth. These may be signs or symptoms of periodontitis, 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: Vigorougly swish 20 mL (1 tablespoon) 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: Do not use.
Other Information
- This rinse is not intended to replace brushing or flossing
- 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
Water, Glycerin, Xylitol, PEG-40 Hydrogenated Castor Oil, Poloxamer 407, Wintergreen Oil, Menthol, D-Alpha Tocopherol (Vitamin E), Stevia Leaf Extract, Disodium Phosphate, Citric Acid, Eucalyptus Oil, Peppermint Oil, Thyme Oil, Menaquinone-7 (Vitamin K2 MK-7)
Package Label.Principal Display Panel
08926.1 (08926.1)
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