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

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated June 30, 2021

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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