Label: MIRAKEL- benzocine 10%, resorcinol 1.5% cream

  • 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 July 15, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Active ingredients Purpose
    Benzocaine 10% .........................................................External Analgesic
    Resorcinol 1.50%........................................................External Analgesic

    Active Ingredients

  • Uses

    Uses temporary relief of pain, itching and discomfort associated with:

    ■ rashes
    ■ minor cuts

    ■ minor burns
    ■ minor skin irritations

    ■ insect bites

    Uses

  • Warnings

    Warning

    Warnings
    For external use only
    When using this product ■ avoid contact with eyes ■ do not apply
    over large areas of the body

    Stop use and ask a doctor if ■ condition worsens or symptoms persist
    for more than 7 days, or clear up and occur again within a few days

    Keep out of reach of children. If swallowed, get medical help or
    contact a Poison Control Center immediately.

  • Keep Out Of Reach of Children

    Keep Out Of Reach Of Children

    Keep out of reach of children. If swallowed, get medical help or
    contact a Poison Control Center immediately.

  • Directions

    Directions

    Directions
    ■ adults and children 12 years and older: apply small amount to
    affected area not more than 3-4 times a day.
    ■ children under 12 years of age: consult a doctor

  • Other Information

    Other Information

    Other Information ■ store at 20-25°C (68-77°F)
    ■ skin is more sensitive to sunlight when using this product.
    ■ keep tightly closed after use.

  • Inactive Ingredients

    Inactive Ingredients

    Inactive ingredients aloe barbadensis (aloe vera) leaf extract,
    butylated hydroxytoluene, carbomer, cetyl
    alcohol, cholecalciferol, edetate disodium,
    glyceryl monostearate, isopropyl palmitate,
    maltodextrin, mentha piperita (peppermint) oil,
    methylparaben, mineral oil, PEG-40 hydrogenated
    castor oil, PEG-100 stearate,petrolatum,
    propylene glycol, propyl-paraben, purified
    water, retinyl palmitate, sodium lauryl sulfate,
    thymus vulgaris (thyme) flower leaf oil, tocopheryl
    acetate triethanolamine, xanthan gum.

  • Questions

    Questions

    Questions? Call 1-888-855-5681

  • Purpose

    Purpose


    Active ingredients Purpose
    Benzocaine 10% .........................................................External Analgesic
    Resorcinol 1.50%........................................................External Analgesic

  • Pricipal Display Panel

    Label Main Complete

  • INGREDIENTS AND APPEARANCE
    MIRAKEL 
    benzocine 10%, resorcinol 1.5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78589-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.1 g  in 1 g
    RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL0.015 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN) 0.03 g  in 1 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78589-100-011 g in 1 TUBE; Type 0: Not a Combination Product06/01/2020
    2NDC:78589-100-021 g in 1 BOX; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2020
    Labeler - Sanvio, Inc. (100812165)
    Registrant - Sanvio, Inc. (100812165)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanvio, Inc.100812165manufacture(78589-100)