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Drug Facts
DISTR. BY ORAL-B, A DIVISION
OF PROCTER & GAMBLE,
CINCINNATI, OH 45202
Oral B Mouth Sore Rinse
FDA Label NDC 84126-603
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Oral B Mouth Sore (NDC 84126-603). 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 other, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Hydrogen Peroxide 1.5%
Purpose
oral debriding/wound cleansing
Uses
- For temporary use in cleansing minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.
- Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.
- For temporary use to cleanse canker sores.
Warnings
- Do not use this product for more than 7 days unless directed by a dentist or doctor.
- If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
Otc - Keep Out Of Reach Of Children
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 yrs. & older:
Rinse with 20 mL
Swish around in the mouth over the affected area for at least 1 minute and then spit out.
Use up to four times daily after meals and at bedtime or as directed by a dentist or doctor.
do not swallow
- children 6 years to under 12 years of age:
- children under 6 years of age:
supervise use
do not use
Inactive Ingredients
citric acid, flavor, glycerin, poloxamer 407, propylene glycol, sodium citrate, sodium hexametaphosphate, sodium saccharin, sucralose, water
Questions?
1-800-862-7442
Principal Display Panel - 475 Ml Bottle Label
+ WITH HYDROGEN PEROXIDE
Dosing Cup Included
HYDROGEN PEROXIDE ORAL DEBRIDING AGENT
Oral-B
MOUTH SORE
ORAL RINSE
SCIENTIFICALLY
FORMULATED
For Mouth Sores Including:
- Canker Sores
- Cheek Bites
- Braces & Denture Irritations
SOOTHING MINT
475 mL (16 FL OZ)
Label (Capture.pdf)
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