Label: HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid

  • NDC Code(s): 55910-268-16, 55910-268-32
  • Packager: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
  • 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 October 24, 2022

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

  • Active ingredient

    Hydrogen peroxide 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 one week

    Ask a doctor before use if you have

    • deep or puncture wounds, animal bites or serious burns

    Stop use and ask a doctor if

    • swelling, rash, or fever develops
    • the condition persists or gets worse
    • sore mouth symptoms do not improve in 7 days 
    • irritation, pain or redness persists or worsens

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    For use as a first aid antiseptic:

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

    For use as an oral debriding agent (oral rinse):

    • adults and children 2 years of age and over:
      • mix with an equal amount of water
      • swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow.
      • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
    • children under 12 years 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 and in a dark place at room temperature.
    • Do not shake bottle. Hold away from face when opening.
  • Inactive ingredient

    purified water

  • Questions or comments?

    Call toll free 1-866-4-REXALL

  • Princiapl Display Panel

    Hydrogen Peroxide USP

    Topical Solution USP 3% H2 O2

    First Aid Antiseptic

    Oral Debriding Agent

    • For treatment of minor cuts and abrasions

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY OLD EAST MAIN CO.

    100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

  • Package Label

    Hydrogen Peroxide 3%

    REXALL Hydrogen Peroxide

     

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE  3 PERCENT
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-268
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-268-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/30/202001/31/2025
    2NDC:55910-268-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/30/202001/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/30/202001/31/2025
    Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)