Label: HUMCO HYDROGEN PEROXIDE- hydrogen peroxide 3% liquid

  • NDC Code(s): 0395-1113-16, 0395-1113-28, 0395-1113-94
  • Packager: Humco Holding Group, Inc.
  • 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 March 17, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Hydrogen Peroxide 3%

  • Purpose

    Antiseptic

  • Uses

    As an antiseptic to help prevent infection in minor cuts, scrapes, burns.

  • SPL UNCLASSIFIED SECTION

    As an oral rinse for temporary use in cleaning of minor wounds or irritation/inflammation to the mouth and gums resulting from minor dental procedures, orthodontic appliances or accidental injury.

  • Warnings

    For external use except when used as an oral rinse.

    Do not use in the eyes.

    Do not apply over large areas of the body.

    Do not use longer than 1 week unless directed by a dentist or doctor.

  • Ask a doctor before use if you have:

    deep or puncture wounds, animal bites, serious burns.

  • Stop use consult a dentist or doctor if:

    condition persists or gets worse, sore mouth symptoms do not improve in 7 days, irritation, pain, redness or fever develop.

  • Keep out of reach of children.

    In case of acciedntal ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    For antiseptic use: Clean the affected area, apply a small amount on the area 1 to 3 times daily.

    For oral rinse use: Adults and children 2 years and older mix with an equal amount of water and swish around and over the affected area then spit out. Use up to 4 times daily or as directed by a dentist or a doctor.

    Children under 2 years of age: consult a doctor.

  • Other information

    Keep tightly closed and at controlled room temperature 15-30C (59-86F).

    Do not shake.

  • Inactive ingredient

    Purified water

  • Principal package display

    Label 16 oz

    image description

  • New Label

    New Label

  • INGREDIENTS AND APPEARANCE
    HUMCO HYDROGEN PEROXIDE 
    hydrogen peroxide 3% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-1113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-1113-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2017
    2NDC:0395-1113-283800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2017
    3NDC:0395-1113-94113 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/25/1998
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114label(0395-1113) , manufacture(0395-1113) , pack(0395-1113) , analysis(0395-1113)
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