ORAL B MOUTH SORE SPECIAL CARE RINSE- hydrogen peroxide rinse

Oral B Mouth Sore by

Drug Labeling and Warnings

Oral B Mouth Sore by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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.

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:

supervise use

• children under 6 years of age:

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

SPL UNCLASSIFIED SECTION

DISTR. BY ORAL-B, A DIVISION

OF PROCTER & GAMBLE,

CINCINNATI, OH 45202

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)

INGREDIENTS AND APPEARANCE

ORAL B MOUTH SORE  SPECIAL CARE RINSE
hydrogen peroxide rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-603
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	0.03 mL  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-603-16	475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/02/2020
2	NDC: 84126-603-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/02/2020

Labeler - The Procter & Gamble Manufacturing Company (004238200)