Label: HYDROGEN PEROXIDE solution

  • NDC Code(s): 67751-001-04
  • Packager: Navajo Manufacturing Company Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2024

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

  • Drug Facts

  • Active Ingredient

    Hydrogen Peroxide (stabilized 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, mucous, 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 1 week
  • ASK DOCTOR

    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

    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 area 1 to 3 times daily
    • 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
    • children under 12 years of age 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 in a cool dark place. Do not shake bottle. Hold away from face when opening.

  • Inactive Ingredient

    Purified Water

  • PRINCIPAL DISPLAY PANEL

    Handy Solutions

    Hydrogen Peroxide

    3% USP Topical Solution

    first aid antiseptic 

    oral debriding agent

    TAMPER EVIDENT CAP FOR YOUR PROTECTION.

    IF RING-BAND IS DETACHED FROM CAP OR MISSING DO NOT USE.

    4 FL OZ (118 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-001
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-001-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/24/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00304/24/2013
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Registrant - Hydrox Laboratories (025164302)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hydrox Laboratories025164302label(67751-001) , manufacture(67751-001) , pack(67751-001)