Label: HYDROGEN PEROXIDE solution

  • NDC Code(s): 11822-0871-4, 11822-0871-5, 11822-0871-7
  • Packager: Rite Aid
  • 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 April 20, 2022

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  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

    Purpose

    First aid antiseptic
    Oral debriding agent

  • Use

    • 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 then 1 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 right away

  • Directions

    First aid antiseptic:
    •clean the affected area
    •apply a small amount of product on the affected area 1 to 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 the 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

  • Other information

    keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

  • Inactive ingredient

    purified water

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: RITE AID
    30 HUNTER LANE, CAMP HILL PA 17011

  • principal display panel

    RITE AID

    NDC 11822-0871-7

    first aid antiseptic

    hydrogen peroxide topical solution USP

    For treatment of minor cuts & abrasions

    10 FL OZ (295 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0871
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE.3 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0871-4.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/1993
    2NDC:11822-0871-5.710 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/1993
    3NDC:11822-0871-7.295 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/11/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/11/1993
    Labeler - Rite Aid (014578892)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(11822-0871)