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:

Bottle

CREMA CERO ZINC OXIDE SKIN PROTECTANT DIAPER RASH BABY ORIGINAL FORMULA 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50573-0011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION49 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
LANOLIN (UNII: 7EV65EAW6H)  
CASTOR OIL (UNII: D5340Y2I9G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50573-0011-1110 g in 1 BOTTLE; Type 0: Not a Combination Product04/30/202104/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/30/202104/30/2024
Labeler - Laboratorios Cero S.A (880165766)

Revised: 6/2021
Document Id: c5fa2a4c-84c8-33e6-e053-2a95a90adc8a
Set id: c1708f58-3f1f-449f-e053-2a95a90aa4d4
Version: 3
Effective Time: 20210630
 
Laboratorios Cero S.A