Label: 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 October 7, 2020

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  • SPL UNCLASSIFIED SECTION

    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 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 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 - 946 mL Bottle Label

    Tamper evident cap for your protection

    if ring-band is broken or missing, do not use.

    Part # HSN2239

    NDC #87010-001-32

    HYDROGEN PEROXIDE

    3% USP 10 VOLUME

    3%

    FIRST AID ANTISEPTIC
    Made in USA

    32 FL. OZ. (946 mL)

    peroxide

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:87010-001
    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:87010-001-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/07/2018
    2NDC:87010-001-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/1993
    Labeler - Healthwell (004227758)
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