Otc - Active Ingredient
Hydrogen peroxide 1.5% (w/v)
Hydrogen Peroxide Oral Rinse
FDA Label NDC 59883-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Den-mat Holdings, Llc for the product Hydrogen Peroxide Oral Rinse (NDC 59883-201). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Bacteria reducing rinse and oral debriding agent/oral wound cleanser
Indications & Usage
For temporary use to reduce bacteria in the mouth before and after dental procedures. Other uses include removal of oral debris and cleansing or healing of minor mouth irritations, such as canker sores, minor wounds and minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury or other irritations of the mouth and gums.
Warnings
Do not use this product for more than 7 days unless directed by a dentist or physician.
Otc - When Using
do not swallow
Otc - Stop Use
Stop use and ask a doctor if
- sore mouth symptoms do not improve within 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
Otc - 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.
Directions
- Adults and children 6 years of age and older: fill dose cup to 10 mL (two teaspoons) and rinse around in the mouth over affected area for at least 1 minute, then spit out.
- Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician
- Children under 12 years of age should be supervised in the use of the product
- Children under 6 years of age: consult a dentist or physician
Other Information
store at controlled room temperature 68-77° (20-25°C)
Inactive Ingredient
Water, glycerin, sodium citrate, cremophor RH 40, flavor, tego betain ZF, citric acid, sodium benzoate, sodium fluoride, xylitol, sodium hydroxide
Otc - Questions
800-433-6628
* Please review the disclaimer below.
