VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]

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VITACILINA BEBE DIAPER RASH (ALLANTOIN, ZINC OXIDE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]
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NDC 54312-525-16
Set ID 39726b59-bd85-4541-80e5-4f2919842dca
Category HUMAN OTC DRUG LABEL
Packager Compania Internacional de Comercio, S.A.P.I de C.V.
Generic Name
Product Class
Product Number
Application Number PART347
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  • Drug Facts


  • Active ingredients

    Allantoin 1%
    Zinc Oxide 25%

    Purpose

    Skin Protectant

  • Uses

    • Treats and prevents diaper rash

    • Protects minor skin irritation associated with diaper rash

    • Helps seal out wetness

  • Warnings

    • For external use only
    • Avoid contact with the eyes
    • If condition worsens or does not improve within 7 days, consult a doctor

    Keep out of the reach of children


  • Directions

    Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. Apply ointment as often as necesary with each diaper change, especially at bedtime or anytime when exposure to wet diapers maybe prolonged. 

  • Inactive Ingredients

    Petrolatum, corn starch, fragrance, lanolin, methylparaben, mineral oil, propylparaben, vitamin A (palmitate), vitamin D (calciferol), vitamin E (tocopherol).

  • Package Labeling:

    Outer Package5Outer Package6Inner Package5

  • INGREDIENTS AND APPEARANCE
    VITACILINA BEBE DIAPER RASH 
    allantoin, zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54312-525
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN10 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION250 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    VITAMIN A (UNII: 81G40H8B0T)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54312-525-161 in 1 PACKAGE09/30/2013
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/30/2013
    Labeler - Compania Internacional de Comercio, S.A.P.I de C.V. (815039995)
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