Label: MIRAPHA30- 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 June 15, 2020

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  • Active ingredient

    hydrogen peroxide 3%

  • Purpose

    Antimicrobial

  • Uses

    Hand Sanitizer to reduce bacteria on the skin

  • Warnings

    For external use only: hands

    Flammable, keep away from heat and flame.

  • When using this product

    Keep out of eyes. In case of contact with eyes, rinse thoroughly with water. Do not inhale or ingest

  • Stop use and ask a doctor if

    Irritation or redness develops. Condition persists for more than 72 hours

  • Keep out of reach of children.

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

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants

  • Other information

    Do not store above 105F. May discolor certain fabrics

  • Inactive ingredients

    Glycerin, Water, Bis(D-gluconato-01, 02)zinc

  • Package Label

    500ml NDC: 78780-201-01 Label

  • INGREDIENTS AND APPEARANCE
    MIRAPHA30 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78780-201
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78780-201-01500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/15/2020
    Labeler - ECOCOSMETICS (695538802)
    Registrant - ECOCOSMETICS (695538802)
    Establishment
    NameAddressID/FEIBusiness Operations
    ECOCOSMETICS695538802manufacture(78780-201)
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