DIAPER RASH SKIN PROTECTANT CREMA CERO- zinc oxide cream

Diaper Rash Skin Protectant Crema Cero by

Drug Labeling and Warnings

Diaper Rash Skin Protectant Crema Cero by is a Otc medication manufactured, distributed, or labeled by Laboratorios Cero S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                          

Zinc Oxide 4.9%

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses:

Helps treat and prevent diaper rash.

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

WARNINGS

Warnings

For external use only.

When using this product 

• do not get into eyes.

STOP USE

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.
  

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

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

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

INACTIVE INGREDIENT

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

QUESTIONS

Questions?: Call 305-599-3414

DESCRIPTION

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

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.

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.

INGREDIENTS AND APPEARANCE

DIAPER RASH SKIN PROTECTANT CREMA CERO 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50573-3550
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
LANOLIN (UNII: 7EV65EAW6H)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50573-3550-3	110 g in 1 TUBE; Type 0: Not a Combination Product	02/24/2010	05/31/2020
2	NDC: 50573-3550-1	30 g in 1 JAR; Type 0: Not a Combination Product	02/24/2010	05/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/24/2010	05/31/2020

Labeler - Laboratorios Cero S.A. (880165766)

Registrant - Laboratorios Cero S.A. (880165766)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Cero S.A.		880165766	manufacture(50573-3550)