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 February 2, 2023

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  • 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 redess 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 affected area 1 to 3 times a day
    • may be coverd with a sterile bandage
    • if bandaged, let dry first

    Oral debriding agent (oral rinse): 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 minure, 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
    • 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 from face when opening.

  • Inactive ingredients

    purified water

  • SPL UNCLASSIFIED SECTION

    Distributed by: Cariba International

    P.O. Box 1208

    Safety Harbor, Florida 34695

    MADE IN USA WITH US AND FOREIGN COMPONENTS

  • principal display panel

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

    CARIBA CARE

    HYDROGEN PEROXIDE

    TOPICAL SOLUTION USP

    FIRST AID ANTISEPTIC

    ORAL DEBRIDING AGENT

    For Treatment of Minor Cuts and Abrasions

    For Use as a Gargle or Rinse

    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:67860-871
    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:67860-871-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/28/2016
    Labeler - Cariba International (049354067)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(67860-871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(67860-871)