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

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

Drug Labeling and Warnings

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

Drug Details [pdf]

CREMA CERO ZINC OXIDE SKIN PROTECTANT DIAPER RASH BABY ORIGINAL FORMULA- zinc oxide ointment 
Laboratorios Cero S.A

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Drug Facts

Active ingredient

Zinc oxide 4.9%

Purpose

Skin protectant

Uses

• helps treat and prevent diaper rash
• protects minor skin irritation 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 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 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

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

Inactive ingredients

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

Package Labeling:

CREMA CERO ZINC OXIDE SKIN PROTECTANT DIAPER RASH BABY ORIGINAL FORMULA 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50573-0011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	49 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50573-0011-1	110 g in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2021	04/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/30/2021	04/30/2024

Labeler - Laboratorios Cero S.A (880165766)

Revised: 6/2021

Document Id: c5fa2a4c-84c8-33e6-e053-2a95a90adc8a

34390-5

Set id: c1708f58-3f1f-449f-e053-2a95a90aa4d4

Version: 3

Effective Time: 20210630