Label: PHARMACYS PRESCRIPTION HYDROGEN PEROXIDE- hydrogen peroxide liquid

  • 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 7, 2018

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  • Active Ingredient

    Active ingredient (by volume)

    Hydrogen peroxide 3%

  • Purpose

    First aid antiseptic/oral debriding agent.

  • Warnings

    Warnings

    For external use only.

  • Stop Use

    Stop use and ask a doctor if: the condition persists or gets worse, sore mouth symptoms do not improve within 7 days, irritation, pain or redness persists or worsens, swelling, rash or fever develops.

  • Keep out of reach of children

    Keep this and all drugs out of the reach of children. If swallowed, seek professional or contact a Poison Control Center immediately.

  • Directions

    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 bandage, 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.

  • Inactive Ingredients

    Inactive ingredient

    Purified water, also contains 0.001% Phosphoric acid as a stabilizer.

  • Indications & Usage Section

    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.

  • PRINCIPAL DISPLAY PANEL

    Hydrogen Peroxide 01

  • INGREDIENTS AND APPEARANCE
    PHARMACYS PRESCRIPTION HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72197-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72197-008-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/31/2018
    Labeler - American Consumer Products Corp (081101181)
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