Label: HYDROGEN PEROXIDE TOPICAL SOLUTION U.S.P- hydrogen peroxide solution

  • 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 March 5, 2021

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  • DRUG FACTS

  • Active Ingredient

    Hydrogen Peroxide 3%

    Purpose

    First Aid Antiseptic

  • USES

    first aid to help prevent the risk of infection in minor cuts, scrapes, and burn aids in the removal of phlegm, mucus or other secretions associated with occasional sore mouth.

  • Warnings

    For External Uses only, avoid swallowing

    DO NOT USE

    in the eyes or apply over large areas of the body longer than one week.

    Stop use and ask doctor if:

    condition persist or worsens, sore mouth symptoms do not improve in 7 days irritation pain or redenss persists or worsens swelling, rash of fever develops. Deep 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.

  • DIRECCTION FOR USE A FIRST AID ANTISEPTIC

    Clean affected area. Apply small amount of product on affected area 1-3 times day. May be covered with a sterile bandage. If bandaged let dry first.

    FOR USE AS AN ORAL RINSE AGENT

    Adults and children 2 years of age and over: mix with an equal amount of water. Swish around mouth over the affected area for at least 1 minute and then spilt out. Do Not Swallow. Use up to 4 times daily or as directed by your dentist or doctor.

  • Other Information

    Keep tightly closed and in dark place at room temperature. Do not shake bottle. Hold away from face when opening

  • Inactive Ingredient

    USP Water

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE TOPICAL SOLUTION U.S.P 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74830-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74830-002-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2021
    Labeler - Economy Polymers and Chemicals (008087603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Economy Polymers and Chemicals008087603manufacture(74830-002)
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