Label: HCS HYDROGEN PEROXIDE 3%- hydrogen peroxide liquid

  • NDC Code(s): 83506-001-04, 83506-001-08, 83506-001-16
  • Packager: Concordance Healthcare Solutions, LLC.
  • 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 August 14, 2023

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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, 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 have deep 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 83506-001-16

    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 THE SEAL IS BROKEN OR MISSING DO NOT USE

    16 FL OZ (1 PT) 473 mL

    Principal Display Panel – 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HCS HYDROGEN PEROXIDE 3% 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83506-001
    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:83506-001-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/14/2023
    2NDC:83506-001-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/14/2023
    3NDC:83506-001-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/14/2023
    Labeler - Concordance Healthcare Solutions, LLC. (080220245)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ken Prima Cosmeceuticals SDN BHD865792209MANUFACTURE(83506-001)
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