Label: HYDROGEN PEROXIDE solution

  • NDC Code(s): 0404-0001-01, 0404-0001-08, 0404-0001-16
  • Packager: Henry Schein Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2024

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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 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 havedeep 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 (1-800-222-1222).

  • Directions

    First Aid Antiseptic
    • clean the affected area
    • apply a small amount of product on the area 1 to 3 times a day
    • may be covered with a sterile bandage
    • if bandaged, let dry first

    Oral Debriding Agent (oral rinse):

    Adults and children 2 years of age & 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

  • Questions or Comments?

    1-800-472-4346

  • PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label

    Item # 112-7070
    NDC 0404-0001-01

    HENRY SCHEIN ®

    3 % Hydrogen
    Peroxide Solution

    U.S.P. FIRST AID ANTISEPTIC
    Tamper evident cap for your protection. If ring-band
    is detached from cap or missing do not use.

    Distributed by (in US Only):

    HENRY SCHEIN INC.
    135 Duryea Road
    Melville, NY 11747 USA

    Rev. Date 2018/06 Made in the USA

    128 FL OZ (1 Gal.) • 3.79 L

    Principal Display Panel - 3.79 L Bottle Label

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0001
    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:0404-0001-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2014
    2NDC:0404-0001-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2014
    3NDC:0404-0001-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00306/01/2014
    Labeler - Henry Schein Inc. (012430880)
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