Label: PEROX-A-MINT SOLUTION- hydrogen peroxide mouthwash

  • NDC Code(s): 53462-075-30, 53462-075-40, 53462-075-60
  • Packager: Sage Products, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 29, 2024

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  • Active ingredient

    Hydrogen Peroxide 1.5%

  • Purpose

    Oral Debriding Agent

  • Use

    Aids in the removal of secretions associated with sore mouth

  • Warnings

    Do not use:

    • For more than 7 days unless told to do so by a doctor.
    • Avoid swallowing.

    Stop use and ask a doctor if:

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

    Keep out of reach of children.  If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Use up to 4 times daily or as directed by a dentist or doctor.
    • Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp. Instruct to expectorate.
    • Children under 12 years of age:  supervise use.
    • Children under 3 years of age:  consult a dentist or doctor.
  • Inactive Ingredients

    Blue 1 (CI42090), menthol flavor, phosphoric acid, polysorbate 80, sodium saccharin, Water, Yellow 6 (CI15985)

  • QUESTIONS

    Questions? Call toll free 800-323-2220

  • Perox-A-Mint Solution

    Perox-A-Mint Bottle (44 mL)

    Perox-A-Mint Burst Pouch (7 mL)

  • INGREDIENTS AND APPEARANCE
    PEROX-A-MINT SOLUTION 
    hydrogen peroxide mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-075
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-075-3044 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/1998
    2NDC:53462-075-40237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/1998
    3NDC:53462-075-607 mL in 1 PACKET; Type 0: Not a Combination Product05/21/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02205/21/1998
    Labeler - Sage Products, LLC (054326178)
    Registrant - Sage Products, LLC (054326178)