Label: HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid

  • NDC Code(s): 55319-268-16, 55319-268-32
  • Packager: Family Dollar (FAMILY WELLNESS)
  • 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 August 28, 2019

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

  • Active ingredient

     Hydrogen peroxide 3%

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  • Purpose

     First aid antiseptic/oral debriding agent

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  • Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes, and burns
    • aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
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  • Warnings

    For external use only.

    Do not use

    • in the eyes or apply over large areas of the body
    • longer than one week

    Ask a doctor before use if you have

    • deep puncture wounds, animal bites or serious burns

    Stop use and ask a doctor if

    • swelling, rash, or fever develops
    • the condition persists or get worse
    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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  • Directions

    For use as a first aid antiseptic:

    • clean affected area
    • if bandaged, let dry first
    • apply small amount of product on affected area 1-3 times a day
    • may be covered with sterile bandage

    For use as an oral debriding agent (oral rinse):

    • adults and children 2 years of age and over:
      • mix with an equal amount of water
      • swish around in the mouth over affected area for at least 1 minute and then spit it out. Do not swallow.
      • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
    • children under 12 years should be supervised in the use of this product
    • children under 2 years of age: consult a doctor or dentist 
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  • Other information

    • keep tightly closed and in a dark place at room temperature
    • do not shake bottle. Hold away from face when opening
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  • Inactive ingredient

    purified water 

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  • Principal Display Panel

    Hydrogen Peroxide

    3% USP

    First Aid Antiseptic/Oral debriding Agent

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC

    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

    Questions or comments?

    Call 1-877-753-3935

    Monday-Friday 9AM-5PM EST

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

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  • Package Label

    Hydrogen Peroxide 3%

    FAMILY WELLNESS Hydrogen Peroxide 3% USP

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  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE  3 PERCENT
    hydrogen peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-268
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 2.65 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55319-268-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2014
    2 NDC:55319-268-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 08/31/2014
    Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
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