Active Ingredient
Zinc Oxide 18%
Manzatin-e Diaper Rash Skin Protectant Ointment
FDA Label NDC 55715-002
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-e Diaper Rash Skin Protectant (NDC 55715-002). 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 ingredient, purpose, uses, warnings, when using this product, stop using 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
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,
Package Label.Principal Display Panel
Manzatin-e Inner Package (Manzatin English Inner)
Manzatin-e Outer Package (Manzatin English Outer)
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