Label: 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 October 17, 2022

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  • 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, scraps and burns

  • WARNING

    For external use only

  • DO NOT USE

    -in the eyes or apply over large areas of the body
    -longer than one week

  • Ask a doctor before use if you have

    -deep puncture wounds, animal bites or serious burns

  • STOP USE AND ASK A DOCTOR IF

    -swelling, rash or fever develops
    -the condition persists or gets worse
    -sore mouth symptoms do not improve in 7 days
    -irritation, pain, or redness persists or worsen

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control center (1-800-222-1222) right away

  • DIRECTIONS

    For use as a first aid antiseptic:
    -clean affected area
    -if bandaged, let dry first
    -apply small amount of product on affected area 1-3 times a day
    -may be covered with a sterile bandage
    For use as an oral debriding agent (oral rinse)
    -adults and children 2 years of age and over
    -mix with and equal amount of water
    -swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow
    -use up to 4 times daily after meals and bedtime or a 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 doctor or dentist

  • OTHER INFORMATION

    -keep tightly close and in a dark place at room temperature
    -do not shake bottle: hold away from face when opening

  • INACTIVE INGREDIENT

    Purified water

  • Principal Display

    Label Margrey
    Hydrogen peroxide
    Topical solution USP
    Do not use if seal under cap
    is broken or missing
    32FL OZ 946ml

    Distributed by BROSANT Group LLC, 15900 La cantera Parkway Suite 20255, San Antonio TX 78256, USA
    Telephone: (210) 568-0444

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77210-0035
    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) 70 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77210-0035-1946 mL in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/17/2022
    Labeler - EXPORTADORA IN AND OUT S DE RL DE CV (951577298)
    Registrant - MARGREY INDUSTRIAL SA DE CV (814572392)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARGREY INDUSTRIAL SA DE CV814572392manufacture(77210-0035)
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