Label: 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 January 16, 2023

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  • Active Ingredient

    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 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 worsen

  • Keep out of reach of children

    In case of ingestion, 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

    -if bandaged, let dry first

    -apply small amount of product on affected area 1-3 times a day

    -may be covered with a sterile bandage

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

    -adults and children 2 years of age and over:

    -mix with and 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 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 od this product

    children under 2 years of age: consult a doctor or dentist

  • Other information

    -keep tightly closed and in a dark place at room temperature

    -do not shake botlle. Hold away from face when opening

  • Inactive ingredient

    purified water

  • PRINCIPAL DISPLAY PANEL

    bioliving

    3% hydrogen peroxide

    topical solution USP

    Tamper evident: do not use if seal under cap is broken or missing

    32 FL OZ (1 QT) 946 mL
    Principal Display

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83123-0012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 97 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83123-0012-1946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/16/2023
    Labeler - BROSANT GROUP LLC (117037683)
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