Label: HUMCO HYDROGEN PEROXIDE- hydrogen peroxide 3% liquid

  • NDC Code(s): 0395-1113-16, 0395-1113-18, 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 November 9, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Hydrogen Peroxide 3%

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  • Purpose

    Antiseptic

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  • Uses

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

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  • 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.

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  • 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.

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  • Ask a doctor before use if you have:

    deep or puncture wounds, animal bites, serious burns.

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  • 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.

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  • Keep out of reach of children.

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

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  • 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.

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  • Other information

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

    Do not shake.

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  • Inactive ingredient

    Purified water

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  • Principal package display

    Label 16 oz

    image description

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  • New Label
  • INGREDIENTS AND APPEARANCE
    HUMCO HYDROGEN PEROXIDE 
    hydrogen peroxide 3% liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-1113
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 30 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0395-1113-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/30/2017
    2 NDC:0395-1113-18 3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/30/2017
    3 NDC:0395-1113-94 113 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/30/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/25/1998
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    Name Address ID/FEI Business Operations
    Humco Holding group, Inc. 825672884 label(0395-1113) , manufacture(0395-1113) , pack(0395-1113) , analysis(0395-1113)
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