Label: HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid

  • NDC Code(s): 63868-926-08, 63868-926-16, 63868-926-32
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • 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 8, 2019

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

  • 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

    • 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) immediately.

  • Directions

    • 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
    • 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
        • 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 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 1-248-449-9300 Monday-Friday 9AM-5PM EST

  • Princiapl Display Panel

    3% USP

    Hydrogen Peroxide

    First Aid Antiseptic

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

    FL OZ (mL)

    Distributed by C.D.M.A., Inc.©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

  • Package Label

     Hydrogen peroxide 3%

    Quality Choice 3% Hydrogen Peroxide

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE  3 PERCENT
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-926
    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:63868-926-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201412/30/2021
    2NDC:63868-926-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201412/30/2021
    3NDC:63868-926-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201412/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35606/30/201412/30/2021
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)