Label: SHORT TERM ORAL SWAB SYSTEM- 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 January 17, 2019

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

  • Drug Facts

     Active Ingredient Purpose
     PEROX-A-MINT SOLUTION:
     1.5% Hydrogen peroxide Oral debriding agent

  • Use

    Aids in the removal of secretions associated with sore mouth

  • INDICATIONS & USAGE

  • 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 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

    Perox-A-Mint

    • 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.

    Oral Swab System

    • Dip an Oral Swab into the Perox-A-Mint solution.
    • Clean teeth and oral cavity for approximately one minute.
    • Instruct to expectorate.   
    • Apply Mouth Moisturizer as needed.
    • Discard after use.
    • Swabs are intended for single oral use only.
    • Use up to 4 times daily or as directed by a dentist or doctor.
    • Children under 12 years of age should be supervised in the use of this product.
    • 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 (CI42090), Yellow 6 (CI15985)

  • Questions

    Call toll free 800-323-2220

  • SPL UNCLASSIFIED SECTION

    MADE IN U.S.A.

    NOT MADE WITH NATURAL RUBBER LATEX

  • Short Term Oral Swab System with Perox-A-Mint Solution

    Short Term 6000 bagPerox-A-Mint bottle

  • INGREDIENTS AND APPEARANCE
    SHORT TERM ORAL SWAB SYSTEM 
    hydrogen peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-201
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-201-301 in 1 KIT; Type 1: Convenience Kit of Co-Package06/30/2007
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 44 mL
    Part 21 TUBE 14 g
    Part 3
    Part 1 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)  
    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
    11 in 1 KIT
    1NDC:53462-075-3044 mL in 1 BOTTLE, PLASTIC; 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 2 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
    11 in 1 KIT
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 3 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/30/2007
    Labeler - Sage Products LLC (054326178)
    Registrant - Sage Products LLC (054326178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sage Products LLC054326178manufacture(53462-201, 53462-075)