Label: MIEL ROSADA- sodium borate, glycerin solution

  • NDC Code(s): 70242-127-01
  • Packager: Dannso Corp./d.b.a. Essential Products
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 1, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients                                      Purpose

    SODIUM BORATE .............................. Antifungal

    Glycerin ................................................. Moisturizer

  • PURPOSE

    Use

    May help aliviate mouth ulcers

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Antifuncgal

    For External Use Only

  • DOSAGE & ADMINISTRATION

    Directions

    • clean the affected area
    • and dry thoroughly. Apply a thin layer 1 to 3 times daily.
    • May be covered with a sterile bandage, let dry first.
    • Children under 2 years should consult a physician.
  • WARNINGS

    Warnings For external use only

    Avoid Contact with eyes.

    When using this product

    • do not use on irritated skin, in or near eyes or mocous membranes, on wounds or damaged skin, if prone to allergic reaction
    • Fatal if swallowed.

    Stop use and ask a doctor if condition persists or gets worse

  • INACTIVE INGREDIENT

    Inactive Ingredients Extract of Roses, Honey , FD&C red # 40, Purified Water

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    MIEL ROSADA 
    sodium borate, glycerin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70242-127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE0.1 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HONEY (UNII: Y9H1V576FH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70242-127-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/08/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/01/2015
    Labeler - Dannso Corp./d.b.a. Essential Products (059741071)
    Registrant - Dannso Corp./d.b.a. Essential Products (059741071)
    Establishment
    NameAddressID/FEIBusiness Operations
    World Perfume, Inc101312044MANUFACTURE(70242-127)
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