Label: HYDROGEN PEROXIDE liquid

  • NDC Code(s): 36800-214-16, 36800-214-32
  • Packager: TOP CARE (Topco Associates LLC)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 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 puncture wounds, animal bites or serious burns

    Stop use and ask a docotr if

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

    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 doctor or dentist 
  • Other information

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

    purified water 

  • Questions or comments?

    Call toll free 1-888-423-0139

  • Principal Display Panel

    3% USP Hydrogen Peroxide

    FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

    • For treatment of minor cuts, scrapes and burns
    • For use as an antiseptic gargle or rinse

    FL OZ (mL)

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

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    topcare@topco.com

    www.topcarebrand.com

  • Package Label

    Hydrogen Peroxide 3%

    TOPCARE HEALTH 3% Hydrogen Peroxide

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-214
    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:36800-214-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/2009
    2NDC:36800-214-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02205/15/2009
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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