MANZATIN-E DIAPER RASH SKIN PROTECTANT (ZINC OXIDE) OINTMENT [LABORATORIOS ZEPOL S.A.]

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MANZATIN-E DIAPER RASH SKIN PROTECTANT (ZINC OXIDE) OINTMENT [LABORATORIOS ZEPOL S.A.]
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NDC 55715-002-02, 55715-002-06
Set ID cafd084f-8493-4d6e-b256-2d4b4282f866
Category HUMAN OTC DRUG LABEL
Packager Laboratorios Zepol S.A.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredient

    Zinc Oxide 18%      

  • Purpose

    Skin Protectant

  • Uses

    Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.

  • Warnings

    For external use only.

    When using this product

    do not get into eyes

  • Stop using and ask a doctor if

    -condition worsens 
    - symptoms last 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 right away.

  • Directions

    Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. Apply cream liberally as often as necessary, with each diaper  change, especially at bedtime or  anytime when exposure to wet  diapers may be prolonged.

  • Other Information

    - Store in a fresh place,
    preferably below 30 degrees C (86 degrees F).

  • Inactive Ingredients

    Chamomile Flower Extract, CodmLiver Oil, in a special protective lipoid cream base, Corn Starch,

  • PRINCIPAL DISPLAY PANEL

    Manzatin-E Inner Package

  • PRINCIPAL DISPLAY PANEL

    Manzatin-E Outer Package

  • INGREDIENTS AND APPEARANCE
    MANZATIN-E DIAPER RASH SKIN PROTECTANT 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55715-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHAMOMILE (UNII: FGL3685T2X)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55715-002-0290 g in 1 TUBE; Type 0: Not a Combination Product10/01/2009
    2NDC:55715-002-061 in 1 BOX10/01/2009
    2180 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2009
    Labeler - Laboratorios Zepol S.A. (853070985)
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