Manzatin Diaper Rash Skin Protectant Ointment
FDA Label NDC 55715-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Zepol S.a. for the product Manzatin Diaper Rash Skin Protectant (NDC 55715-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses:, warnings:, when using this product, stop use and ask a doctor if, keep out of reach of children., directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses:

→ Warnings:

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions:

→ Other Infomation:

→ Inactive Ingredients:

→ 55715-005-01

→ 55715-005-02

→ 55715-005-03

→ 55715-005-04

→ 55715-005-05

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.