FDA.reportPublic FDA data

Manzatin Diaper Rash Skin Protectant

Manufacturer
Laboratorios Zepol S.A.
Effective date
2023-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:06

Label at a glance#

ProductManzatin Diaper Rash Skin Protectant
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

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. 

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

SPL UNCLASSIFIED SECTION

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

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

55715-005-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

55715-005-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

55715-005-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

55715-005-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

55715-005-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039181zinc oxide 18 % Topical OintmentPSN2
1039181zinc oxide 0.18 MG/MG Topical OintmentSCD2
1039181zinc oxide 18 % Topical OintmentSY2
1039181ZNO 0.18 MG/MG Topical OintmentSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55715-005-01Manzatin Diaper Rash Skin Protectant90 g in 1 TUBEOINTMENT902
55715-005-02Manzatin Diaper Rash Skin Protectant130 g in 1 BOTTLEOINTMENT1302
55715-005-03Manzatin Diaper Rash Skin Protectant170 g in 1 TUBEOINTMENT1702
55715-005-04Manzatin Diaper Rash Skin Protectant180 g in 1 TUBEOINTMENT1802
55715-005-05Manzatin Diaper Rash Skin Protectant235 g in 1 BOTTLEOINTMENT2352

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55715-005MANZATIN DIAPER RASH SKIN PROTECTANT (ZINC OXIDE) OINTMENT [LABORATORIOS ZEPOL S.A.]2Current NDC, Legacy NDC, 5 package rows20231202_5c1618a4-ca08-4814-a556-74e79db618b9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55715-00555715-005-01, 55715-005-02, 55715-005-03, 55715-005-04, 55715-005-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
COD LIVER OILBBL281NWFGIACT
STARCH, CORNO8232NY3SJIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Manzatin Diaper Rash Skin ProtectantZINC OXIDELaboratorios Zepol S.A.5c1618a4-ca08-4814-a556-74e79db618b92023-12-01WarningsExact identifier
ndc (package): 55715-005-01
ndc (package): 55715-005-04
ndc (package): 55715-005-02
ndc (package): 55715-005-05
ndc (package): 55715-005-03
ndc (product): 55715-005
ndc11 (package): 55715000504
ndc11 (package): 55715000502
ndc11 (package): 55715000503
ndc11 (package): 55715000505
ndc11 (package): 55715000501
spl id: 0b7655c5-a49d-c9a5-e063-6394a90a177d
spl set id: 5c1618a4-ca08-4814-a556-74e79db618b9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.