FDA.reportPublic FDA data

Diaper Rash Skin Protectant Ointment Crema Cero Babies

Manufacturer
Laboratorios Cero S.A.
Effective date
2020-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:46:38

Label at a glance#

ProductDiaper Rash Skin Protectant Crema Cero
Active ingredientZINC OXIDE
Label structure13 sections

Storage and handling

Other Information: Store in a fresh place, preferably below 40 celsius (104 fahrenheit)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                          

Zinc Oxide 4.9%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

Uses:

Helps treat and prevent diaper rash.

  • Protects chafed skin due to diaper rash and helps seal out wetness.

WARNINGS SECTION

Warnings

For external use only.

When using this product 


  • do not get into eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Change wet and soiled diapers promptly cleanse the diaper area and allow to dry. 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.

STORAGE AND HANDLING SECTION

Other Information: Store in a fresh place, preferably below 40 celsius (104 fahrenheit)

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Castor Oil, Fragrance, Lanolin, Petrolatum.

OTC - QUESTIONS SECTION

Questions?: Call 305-599-3414

DESCRIPTION SECTION


Manufactured by: Laboratorios Cero S.A
Lot
Exp. Date
Calle 12 Sur 50 G-21, Medellin, Antioquia
e-mail: atencionalcliente@cero.com.co
Columbia
Distributed by: EEUU: Carpa Import and Export Inc.
www.cero.com.co

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diaper Rash Skin Protectant Ointment (Zinc Oxide)

Crema Cero

Cero

Babies

Prevents and Relieves Diaper Rash

How does Crema Cero protect your baby's skin?

Its specialized formulation with Zinc Oxide assures a fast relief when the first sign of irritation occurs.
Regularly applying "Crema Cero" makes it easy to prevent, relieve and treat diaper rash, caused by the humidity produced by the diaper, which is more likely to happen when the contact is prolonged with wet diapers, when there is a change of formula, when the baby begins to eat solids or when the baby is taking antibiotics.'

CREMA CERO relieves the discomfort of the skin caused by irritation and inflammation, creating a protective film that isolates the skin from the humidity and from other factors it is exposed to.

Crema Cero protective, emolient and softening.
It is effective in preventing diaper rashes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Laboratorios Cero S.A.
is interested in your baby's well being, we have developed a variety of specialized products to help care for the delicate skin.

Traditional110gTraditional110gTraditional30gTraditional30gTraditionalOuterBoxTraditionalOuterBox

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z3
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z3
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G3
LANOLININACTIVE INGREDIENT7EV65EAW6H3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U3

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50573-355050573-3550-3, 50573-3550-1

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
CASTOR OILD5340Y2I9GIACT
LANOLIN7EV65EAW6HIACT
PETROLATUM4T6H12BN9UIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 43 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LANOLINLANOLIN7EV65EAW6HSPRAY / NASALNAExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, FILM COATED / ORAL15.29 mgExact identifier — unii candidate
16 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION, SOLUTION / INTRAMUSCULAR525 mgExact identifier — unii candidate
16 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, COATED / ORAL0.9 mgExact identifier — unii candidate
16 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii candidate
16 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / ORAL17 mgExact identifier — unii candidate
16 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, EXTENDED RELEASE / ORAL23.27 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGEL / NASAL429 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSPRAY / NASALNAExact identifier — unii candidate
16 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION / INTRAMUSCULAR885 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE / ORAL1.04 mgExact identifier — unii candidate
16 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / VAGINAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
16 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / RECTAL105 mgExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGRANULE, FOR SUSPENSION / ORAL128 mgExact identifier — unii candidate
16 equally ranked IID candidates

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
9ba61c95-530f-39b9-e053-2a95a90aeedcaf35c688-8cd0-4793-b990-a4de182ee1662020-01-08WarningsExact identifier
spl id: 9ba61c95-530f-39b9-e053-2a95a90aeedc
spl set id: af35c688-8cd0-4793-b990-a4de182ee166

Reported adverse events (FAERS/openFDA)#

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