HYDROGEN PEROXIDE LIQUID [P & L DEVELOPMENT, LLC]

HYDROGEN PEROXIDE LIQUID [P & L DEVELOPMENT, LLC]
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NDC 49580-0014-3, 49580-0014-4
Set ID b9094e2f-1156-4624-a026-2217e130984b
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
Generic Name
Product Class
Product Number
Application Number PART356
  • Active ingredient

    Hydrogen peroxide 3%

  • Purpose

    first aid antiseptic/oral debriding agent

  • Uses

  • Warnings

    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)

  • Do not use

    in the eyes or apply over large areas of the body • longer than one week
    • on deep or puncture wounds, animal bites, or on serious burns.

  • 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 this and all drugs out of the reach of children.

    If swallowed, seek professional assistance
    or contact a Poison Control Center immediately.

  • Directions

    first aid antiseptic:
    • clean affected area
    • apply small amount of product on affected area
    1-3 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 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
    • 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 a controlled room temperature.
    Do not shake bottle. Hold away from face when opening.

  • Inactive ingredient

    purified water

  • principal display panel

    hydrogen peroxide U.S.P

    first aid antiseptic

    tamper evident-do not use if

    printed safety seal on cap is broken or missing

    image of label
  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0014
    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:49580-0014-3946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/04/201312/30/2021
    2NDC:49580-0014-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/04/201312/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35612/04/201312/30/2021
    Labeler - P & L Development, LLC (101896231)

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