Label: SUCTION TOOTHBRUSH WITH PEROX-A-MINT SOLUTION- hydrogen peroxide kit

  • 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 September 20, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

     Active Ingredients Purpose

     Perox-A-Mint Solution

     Hydrogen peroxide 1.5% Oral Debriding Agent

  • Uses

    • Aids in the removal of dental plaque, debris and secretions.
  • INDICATIONS & USAGE

  • Warnings

    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 or worsens.
  • KEEP OUT OF REACH OF CHILDREN

    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.

  • DOSAGE & ADMINISTRATION

  • Directions

    Suction Toothbrush with Perox-A-Mint Solution and Mouth Moisturizer

    • Before opening, turn package over, burst solution packet with thumbs.
    • Peel lid to open.
    • Remove toothbrush and attach to suction line.
    • Clean teeth and oral cavity for approximately 1 minute.
    • To suction, place thumb over port.
    • To clear tubing, rinse with sterile saline or appropriate solution.
    • Discard after use.
    • Use Applicator Swab to apply Mouth Moisturizer as needed.
    • Use up to 4 times daily, or as directed by a dentist or doctor.
    • Children under 12 years of age: supervise use.
    • Children under 3 years of age: consult a dentist or doctor.
    • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
    • Ensure foam is intact after use. If not, remove any particles from oral cavity.
  • Inactive Ingredients

    Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985)

  • Questions

    Call toll-free 800-323-2220

  • Suction Toothbrush with Perox-A-Mint

    Single Use System 6572

  • Perox-A-Mint

    Perox-A-Mint

  • INGREDIENTS AND APPEARANCE
    SUCTION TOOTHBRUSH WITH PEROX-A-MINT SOLUTION 
    hydrogen peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-572
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-572-601 in 1 KIT; Type 1: Convenience Kit of Co-Package06/30/2003
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1 1 
    Part 21 PACKET 7 mL
    Part 31 PACKET 2 g
    Part 1 of 3
    SODIUM BICARBONATE 
    other oral hygiene products
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    INGRSODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 2 of 3
    PEROX-A-MINT SOLUTION 
    hydrogen peroxide mouthwash
    Product Information
    Item 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)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    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
    11 in 1 KIT
    1NDC:53462-075-607 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/21/1998
    Part 3 of 3
    MOUTH MOISTURIZER 
    other oral hygiene products
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
    INGRXYLITOL (UNII: VCQ006KQ1E)  
    INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRCETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    INGRCARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    INGRSPEARMINT OIL (UNII: C3M81465G5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/30/2003
    Labeler - Sage Products, LLC (054326178)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!