FDA.reportPublic FDA data

Crema Cero Zinc Oxide Skin Protectant Diaper Rash Ointment Baby Original Formula

Manufacturer
Laboratorios Cero S.A
Effective date
2021-06-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:41:41

Label at a glance#

ProductCrema Cero Zinc Oxide Skin Protectant Diaper Rash Baby Original Formula
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

helps treat and prevent diaper rash protects minor skin irritation due to diaper rash and helps seal out wetness

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 4.9%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • protects minor skin irritation 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 7 days 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 medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • store in a fresh place protected from sunlight
  • this product contains lanolin; this substance can cause irritation in people with allergies

Inactive ingredients

INACTIVE INGREDIENT SECTION

petrolatum, lanolin, castor (Ricinus communis) seed oil, fragrance (parfum)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

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
50573-001150573-0011-1

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
PETROLATUM4T6H12BN9UIACT
LANOLIN7EV65EAW6HIACT
CASTOR OILD5340Y2I9GIACT
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
c5fa2a4c-84c8-33e6-e053-2a95a90adc8ac1708f58-3f1f-449f-e053-2a95a90aa4d42021-06-30WarningsExact identifier
spl id: c5fa2a4c-84c8-33e6-e053-2a95a90adc8a
spl set id: c1708f58-3f1f-449f-e053-2a95a90aa4d4

Reported adverse events (FAERS/openFDA)#

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