Label: HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid

  • NDC Code(s): 55315-268-16, 55315-268-32
  • Packager: Freds Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • Active ingredient

    Hydrogen peroxide 3%

  • Purpose

    first aid antiseptic/oral debriding agent

  • 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
  • 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 or puncture wounds, animal bites or serious burns

    Stop use and ask a doctor if

    • Swelling, rash, or fever develops
    • the condition persists or gets 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.

  • Directions

    For use as a first aid antiseptic:

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

    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 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 dentist or doctor
  • Other information

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

    purified water

  • Princiapl Display Panel

    Hydrogen Peroxide

    3% USP

    FIRST AID ANTISEPTIC

    ORAL REBRIDING AGENT

    FL OZ (mL)

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

    DISTRIBUTED BY: fred's Inc.

    4300 NEW GETWELL RD.

    MEMPHIS, TN38118

    www.fredsinc.com

    Questions or comments?

    1-855-331-FRED (3733)

  • Package Label

    Hydrogen peroxide 3%

    FRED'S PHARMACY Hydrogen Peroxide

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE  3 PERCENT
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-268
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-268-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/201406/30/2024
    2NDC:55315-268-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/201406/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/31/201406/30/2024
    Labeler - Freds Inc (005866116)
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