HYDROGEN PEROXIDE SOLUTION [H-E-B]

HYDROGEN PEROXIDE SOLUTION [H-E-B]
PDF | XML

NDC 37808-871-43, 37808-871-45, 37808-871-72
Set ID de0e099b-3516-4040-85a1-cc101df75a32
Category HUMAN OTC DRUG LABEL
Packager H-E-B
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

  • Purpose

    First Aid Antiseptic

    Oral debriding agent

  • Use

    • 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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: H-E-B

    SAN ANTONIO, TX 78204

    LOT NUMBER: ON PACKAGE QESTIONS? 1-888-593-0596

  • 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.

    DISTRIBUTED BY: H-E-B, SAN ANTONIO, TX 78204

    LOT NUMBER: ON PACKAGE QUESTIONS? 1-888-593-0593

    16 FL OZ (1 PT) 473 mL

    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
    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)

Related Drugs