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 October 27, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!