Label: GOOD HYGIENE THERAPEUTIC MOUTH RINSE- hydrogen peroxide debriding agent liquid

  • NDC Code(s): 81439-100-16, 81439-110-16, 81439-120-16
  • Packager: Good Hygiene Company
  • 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 May 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient
    Hydrogen Peroxide 1.5% (w/v)

  • PURPOSE

    Purposes

    Oral debriding agent/oral wound cleanser

  • INDICATIONS & USAGE

    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

    Warnings
    Do not use this product for more than 7 days unless directed by a dentist or physician.
    When using this product, do not swallow.
    Stop use and ask a 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. If more than used for rinsing is accidentally swallowed,
    get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    • Adults and children 2 years of age and older: rinse half capful (two teaspoons or
    10 mL) around in the mouth over affected area for at least 1 minute, then spit out
    • Use up to 4 times daily after meals and at bedtime or as directed by a dentist or
    physician
    • Children under 12 years of age should be supervised in the use of the product
    • Children under 2 years of age: consult a dentist or physician

  • OTHER SAFETY INFORMATION

    Other InformationStore at controlled room temperature 68 – 77°F (20 – 25°C)
    Do not use if the safety seal is broken or missing.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Deionized water, xylitol, glycerin, natural flavor, poloxamer
    407, zinc citrate, cardamom, sodium benzoate

  • Product Labeling

    GOOD

    hygiene

    THERAPEUTIC
    MOUTH
    RINSE

    mint + mint

    Freshens         Whitens         Hydrates
     Breath            Teeth             Mouth

    16 fl. oz.

    Good Hygiene Co.
    Los Angeles, CA 91352
    practice@goodhygiene.com
    Made with ♥ in the USA.

    Mint + Mint

    81439-100

    Tropical + Mint

    81439 Tropical Mint

    Citrus + Mint

    81439 Citrus Mint

    res

  • INGREDIENTS AND APPEARANCE
    GOOD HYGIENE THERAPEUTIC MOUTH RINSE 
    hydrogen peroxide debriding agent liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81439-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    CARDAMOM (UNII: 8BC4CUT4JL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81439-100-16475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/01/202105/12/2023
    GOOD HYGIENE THERAPEUTIC MOUTH RINSE 
    hydrogen peroxide debriding agent liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81439-110
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    CARDAMOM (UNII: 8BC4CUT4JL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81439-110-16475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/01/2021
    GOOD HYGIENE THERAPEUTIC MOUTH RINSE 
    hydrogen peroxide debriding agent liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81439-120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    CARDAMOM (UNII: 8BC4CUT4JL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81439-120-16475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/01/2021
    Labeler - Good Hygiene Company (131413215)
    Registrant - Good Hygiene Company (131413215)
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