Label: HYDROGEN PEROXIDE liquid

  • NDC Code(s): 53175-001-04, 53175-001-08, 53175-001-16
  • Packager: Dyad Medical Sourcing, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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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 the 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 or 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.

  • Directions


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

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    HCS

    NDC 53175-001-16

    Solution of
    Hydrogen Peroxide
    3% USP 10 Volume


    FIRST AID ANTISEPTIC
    ORAL DEBRIDING AGENT

    For treatment of minor cuts, scrapes and burns

    For use as a gargle or rinse

    For external use only

    SEALED FOR YOUR PROTECTION

    IF SEAL IS BROKEN OR MISSING DO NOT USE

    Manufactured for:Dyad Medical Sourcing, LLC

    2101 Waukegan Road, Suite 208 Bannockburn, IL 60015

    1-855-241-1773 • info@dyadms.com

    Made in USA #902-HCS0202 Rev. 02

    ©2020 Dyad Medical Sourcing, LLC www.hcsmed.com

    Reorder No. HCS0202

    16 FL OZ (1 PT) 473 mL

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle LabelBack Panel

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53175-001
    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:53175-001-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/10/2012
    2NDC:53175-001-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/10/2012
    3NDC:53175-001-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/10/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00309/10/2012
    Labeler - Dyad Medical Sourcing, LLC (078572603)
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