Label: CAPENT DIAPER RASH- zinc oxide lanolin 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 February 18, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients

    Zinc Oxide 25%

    Lanolin 15.5%

  • PURPOSE

    Purpose

    Skin protectant

    Skin protectant

  • INDICATIONS & USAGE

    Uses ● Helps treat and prevent diaper rash ●Protects minor skin irritation associated with diaper rash ● Helps protect from wetness

  • WARNINGS

    Warnings For external use only

  • WHEN USING

    When using this product ● Do not get into eyes

  • STOP USE

    Stop use and ask a doctor if ● Condition worsens ● Symptoms last for more than 7 days or clear up and occur within a few days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions ● Change wet or 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 any time prolonged exposure to wet diaper is expected

  • SPL UNCLASSIFIED SECTION

    Other information ● store away from heat ● do not use if carton is broken ● see bottom of box and tube for lot number and expiration date

  • INACTIVE INGREDIENT

    Inactive ingredients: allantoin, benzalkonium chloride, BHA, cod liver oil, fragrance, glyceryl monostearate, mineral oil, paraffin, propyl gallate, talc

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CAPENT  DIAPER RASH
    zinc oxide lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59567-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN15.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59567-001-4242.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2013
    Labeler - Laboratorios Columbia S.A. de C.V. (812685253)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Columbia S.A. de C.V.812685253manufacture(59567-001)
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