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
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 13, 2022

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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 not finalpart35605/21/1998
    Labeler - Sage Products, LLC (054326178)
    Registrant - Sage Products, LLC (054326178)
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