Label: HYDROGEN PEROXIDE liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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

  • Active Ingredient

    Hydrogen Peroxide (stabilized) 3%

    Purpose

    First Aid Antiseptic Oral debriding agent

  • Inactive Ingredients:

    Purified water

  • Uses:

    First aid to help prevent the risk of infection in minor cuts, scrapes and burnsAids in the removal of phlegm, mucus, or other secretions associated with ocassional 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.

    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.

    Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

    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 o 3 times a day

    √ May be covered with a sterile bandage.

    √ If bandaged, let dry first.

    Oral debriding agent:

    Adults, children over 2 years of age:

    √ 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.

    √ Children under 12 years of age should be supervised in the use.

    √ Children under 2 years of age: consult a dentist, doctor.

  • Other Information

    √ Keep tightly closed and at controlled room temperature.

    √ Do not shake bottle.

    √ Hold away form face when opening.

  • Question or comments?

    Call 956 728-8899

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67326-354
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE0.3 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67326-354-01946 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00304/15/2020
    Labeler - DEGASA SA DE CV (812771980)
    Establishment
    NameAddressID/FEIBusiness Operations
    DEGASA SA DE CV812771980manufacture(67326-354)