Label: HYDROGEN PEROXIDE solution

  • NDC Code(s): 37808-871-43, 37808-871-45, 37808-871-72
  • Packager: H-E-B
  • 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 June 13, 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

  • Uses

    • 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 than 1 week
  • Ask a doctor before use if you have

    deep or pucture 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 the 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: 

    • adults, children over 2 years of age:
    • mix with equal amount of water
    • swish around in the mouth over the affected area for at least 1 minute, 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 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

  • Principal display panel

    Do not use if printed seal under cap is broken or missing

    H-E-B

    Hydrogen Peroxide

    Topical Solution USP

    First Aid Antiseptic

    Oral Debriding Agent

    • For Treatment of Minor Cuts and Abrasions

    H-E-B

    100 % GUARANTEE PROMISE

    If you aren't completely pleased with this product, we'll be happy to replace it or refund your money. You have our word on it.

    MADE WITH PRIDE & CARE FOR H-E-B 

    646 S. FLORES ST., SAN ANTONIO, TX 78204

    32 FL OZ (1QT) 946mL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-871
    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:37808-871-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2015
    2NDC:37808-871-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/2015
    3NDC:37808-871-72296 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2015
    Labeler - H-E-B (007924756)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37808-871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37808-871)