Label: HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid

  • NDC Code(s): 53441-268-16
  • Packager: National Distribution Network (Smart Choice)
  • 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 December 26, 2018

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) 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

  • Principal Display Panel

    3% U.S.P

    Hydrogen Peroxide

    First Aid Antiseptic

    FL OZ (mL)

    Distributed by

    National Distribution Network

    P.O Box 875

    Melville, NY 11747-0875

    Questions or Comments?

    Call 1-877-753-3935

    Monday-Friday 9AM-5PM EST

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

  • Package Label

    Hydrogen peroxide 3%

    Smart Choice 3% Hydrogen Peroxide

     

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE  3 PERCENT
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53441-268
    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:53441-268-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/201412/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35610/31/201412/31/2021
    Labeler - National Distribution Network (Smart Choice) (045099210)