Label: GNP HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid

  • 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 November 16, 2017

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

  • 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.

    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 accidental 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 Display Panel

    NDC 46122-334-43
    Hydrogen
    Peroxide
    Solution 3% USP
    First Aid Antiseptic
    16 fl oz (1 pt) 473 mL

    Principal Display Panel
NDC 46122-334-43
Hydrogen
Peroxide
Solution 3% USP
First Aid Antiseptic
16 fl oz (1 pt) 473 mL

  • INGREDIENTS AND APPEARANCE
    GNP HYDROGEN PEROXIDE 3 PERCENT 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-334
    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:46122-334-43473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2016
    Labeler - Amerisource Bergen (007914906)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884analysis(46122-334) , manufacture(46122-334) , pack(46122-334) , label(46122-334)