1.5% Hydrogen Peroxide Mouth Rinse

Henry Schein Mouth by

Drug Labeling and Warnings

Henry Schein Mouth by is a Otc medication manufactured, distributed, or labeled by Henry Schein Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HENRY SCHEIN MOUTH- 1.5% hydrogen peroxide rinse 
Henry Schein Inc.

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1.5% Hydrogen Peroxide Mouth Rinse

Active ingredient

Hydrogen peroxide 1.5% (w/w)

Purpose(s)

Oral debriding agent/oral wound cleanser

Uses

• For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor 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 your dentist or physician.

When using this product, do not swallow.

Stop use and ask your doctor if:

• Sore mouth symptoms do not improve within 7 days
• Irritation, pain, or redness persists or worsens
• Swelling, rash, or fever develops

Keep out of reach of children.

• Children under 2 years of age: consult a dentist or physician.
• Children under 12 years of age should be supervised in the use of the product.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• For adults and children 2 years of age or older: rinse 10mL around in the mouth over the affected area for at least 1 minute, than split out.
• Use up to 4 times daily after meals and at bed time, or as directed by a dentist or physician.

Other information

• Store at controlled room temperature, 20-25°C (68-77°F) and away from direct sunlight.
• For your protection, do not use if tamper evident seal under the cap is damaged or missing.

Inactive ingredients

FD&C Blue #1, Menthol, Methyl Salicylate, Poloxamer 407, Polysorbate 20, Propylene Glycol, Sodium Saccharin, Sorbitol, Sucralose, Water

Questions or comments?

Call 1-800-472-4346

Henry Schein® REF 570-2584

MOUTH RINSE

• 1.5% HYDROGEN PEROXIDE
• ALCOHOL FREE

Enjuague bucal

• 1,5 % Peróxido de hidrógeno
• Sin alcohol

Bain de bouche

• 1,5 % De peroxyde d'hydrogène
• Sans alcool

NDC: 0404-0012-01

Mint

Menta

Menthe

16 fl. oz.

(473mL)

Distributed by:

HENRY SCHEIN INC.

135 DURYEA ROAD

Melville, NY 11747 USA

MADE IN USA

Rev.2021/05

HENRY SCHEIN MOUTH 
1.5% hydrogen peroxide rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0404-0012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MENTHOL (UNII: L7T10EIP3A)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-0012-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2021	09/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	06/30/2021	09/30/2023

Labeler - Henry Schein Inc. (012430880)

Revised: 3/2024

Document Id: 12f14093-bde0-451e-e063-6394a90a43e3

34390-5

Set id: c5fbbd40-2acc-2fc3-e053-2a95a90ae927

Version: 3

Effective Time: 20240305