Label: CURAD HYDROGEN PEROXIDE- hydrogen peroxide liquid

  • NDC Code(s): 53329-983-06, 53329-983-23
  • Packager: Medline Industries, Inc.
  • 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 December 18, 2017

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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 puncture wounds, animal bites or serious burns

    Stop use and ask a doctor if

    • 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 product on the affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first

    Oral debriding agent:

    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 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, 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

  • Package/Label Principal Display Panel

    CURAD Hydrogen Peroxide 3% labelCURAD

    NDC 53329-983-23

    HYDROGEN PEROXIDE 3%

    Topical Solution USP

    First Aid Antiseptic

    Oral Debriding Agent

    • For treatment of minor cuts and abrasions

    32 FL OZ (946 mL)

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

  • INGREDIENTS AND APPEARANCE
    CURAD HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-983
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-983-06473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2012
    2NDC:53329-983-23946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2012
    Labeler - Medline Industries, Inc. (025460908)