FDA Label for Gurunanda Oxyfusion
View Indications, Usage & Precautions
Gurunanda Oxyfusion Product Label
The following document was submitted to the FDA by the labeler of this product Gurunanda, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Hydrogen peroxide 1.5%
Purpose
Oral debriding agent/oral antiseptic
Uses
For temporary use in cleansing minor wounds or minor gum inflammation resulting from:
- minor dental procedures
- dentures
- orthodontic appliances
- accidental injury
- canker sores
- other irritations of the mouth and gums
- phlegm
- mucus
- other secretions associated with occasional sore mouth
Aids in the removal of:
Warnings
Warnings
Do Not Use
this product for more than 7 days unless directed by a dentist or doctor
When Using This Product
- do not swallow
- do not exceed recommended dosage
Stop Use And See Your Dotor If
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
Keep Out Of Reach Of Children
if more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)
Directions
Ready to use, no mixxing needed. Close cap tightly.
Adults and children 2 years of age and older: Swish 10 mL around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
Children under 12 years of age: Should be supervised in the use of this product.
Children under 2 years of age: Consult a dentist or doctor.
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
Water, Sorbitol, PEG-40 Hydrogenated Castor Oil, Poloxamer 407, Sodium Benzoate, Xylitol, Wintergreen (Gaultheria procumbens), Oil, Caprylic/Capric/Lauric Triglyceride, D-Alpha Tocopherol (Vitamin E), Citric Acid, Stevia Leaf Extract, Eucalyptus (Eucalyptus globulus) Oil, Peppermint (Mentha piperita) Oil, Thyme (Thymus zygis) Oil, Cholecalciferol (Vitamin D3), Menaquinone-7 (Vitamin K2 MK-7), Menthol
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