Label: AMERICAN RED CROSS 3 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 May 5, 2022

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  • Drug Facts

  • Active ingredient

    Hydrogen Peroxide 3%

    Purpose

    First aid antiseptic

  • Uses

    First aid to help prevent the risk of infection in minor cuts, scrapes and burns

  • 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, animals bites or serious burns

    Stop use and ask a doctor if

    • the condition persists or gets worse 
    • irritation, pain, or redness persists or worsens 
    • swelling, rash, or fever develops

    Keep out of reach of children.

    Is swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • clean the affected area
    • spray a small amount of product on the affected area 1 to 3 times a day
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Other information

    keep tightly closed and at controlled room temperature. Do not shake bottle. Hold srayer tip away from face when opening.

  • Inactive ingredients

    Purified Water

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    AMERICAN RED CROSS 3 HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-4238
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51628-4238-1177 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/10/2021
    Labeler - MY IMPORTS USA LLC (195767988)
    Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt Ltd.726025211manufacture(51628-4238)
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