Label: HENRY SCHEIN MOUTH- 1.5% hydrogen peroxide rinse

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 13, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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

    Do not use this product for more than 7 days unless directed by your dentist or physician.

  • WHEN USING

    When using this product, do not swallow.

  • STOP USE

    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

    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

  • PRINCIPAL DISPLAY PANEL

    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

    Mouth_Rinse_label.jpg

  • INGREDIENTS AND APPEARANCE
    HENRY SCHEIN MOUTH 
    1.5% hydrogen peroxide rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE1.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-0012-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02206/30/2021
    Labeler - Henry Schein Inc. (012430880)