Label: MANZATIN DIAPER RASH SKIN PROTECTANT- zinc oxide ointment

  • NDC Code(s): 55715-005-01, 55715-005-02, 55715-005-03, 55715-005-04, view more
    55715-005-05
  • Packager: Laboratorios Zepol S.A.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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  • Drug Facts

  • Active Ingredients

    Zinc Oxide 18%

    Purpose

    Skin protectant

  • Uses:

    Helps treat and prevent diaperash. 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 use and ask a doctor if

    • condition worsens.
    • symptoms last more than 7days or clear up and occur again within a few days.

    Keep out of reach of children.

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

  • Directions:

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

  • Other infomation:

    Store in a fresh place preferably below 30°C(86°F).

  • Inactive ingredients:

    Chamomile flower extract, Cod liver oil, in special protective lipod cream base, Corn starch.

  • 55715-005-01

    Label

  • 55715-005-02

    Label2

  • 55715-005-03

    Label3

  • 55715-005-04

    Label4

  • 55715-005-05

    Label5

  • INGREDIENTS AND APPEARANCE
    MANZATIN DIAPER RASH SKIN PROTECTANT 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55715-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION180 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55715-005-0190 g in 1 TUBE; Type 0: Not a Combination Product11/01/2021
    2NDC:55715-005-02130 g in 1 BOTTLE; Type 0: Not a Combination Product11/01/2021
    3NDC:55715-005-03170 g in 1 TUBE; Type 0: Not a Combination Product11/01/2021
    4NDC:55715-005-04180 g in 1 TUBE; Type 0: Not a Combination Product11/01/2021
    5NDC:55715-005-05235 g in 1 BOTTLE; Type 0: Not a Combination Product11/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/01/2021
    Labeler - Laboratorios Zepol S.A. (853070985)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Zepol S.A.853070985manufacture(55715-005)
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