Label: PHARMACYS PRESCRIPTION- 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 September 30, 2014

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Hydrogen Peroxide 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.

    • flammable, keep away from fire and flame
    • will produce serious gastric disturbances if ingested

    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 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 bandage, let dry first

    oral debriding agent (oral rinse):

    • adults and children 2 years of age or over:
    • mix with an equal amount of water
    • swish around in the mouth over affected area for atleast 1 minute then spit out
    • use up to 4x 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 temperature
    • do not shake bottle
    • hold away from face when opening
  • INACTIVE INGREDIENT

    purified water, also contains 0.001% phosphoric acid as a stabilizer

  • PRINCIPAL DISPLAY PANEL

    labellabel1label2

  • INGREDIENTS AND APPEARANCE
    PHARMACYS PRESCRIPTION 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:18027-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 97 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:18027-033-16473 g in 1 BOTTLE, PLASTIC
    2NDC:18027-033-10296 g in 1 BOTTLE, SPRAY
    3NDC:18027-033-123785 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2014
    Labeler - AMERICAN CONSUMER PRODUCTS LLC (858427334)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD530766098manufacture(18027-033)
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