Label: CAPENT DIAPER RASH- zinc oxide and lanolin ointment

  • NDC Code(s): 59567-001-42
  • Packager: Laboratorios Columbia S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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  • ACTIVE INGREDIENT

    Active Ingredients

    Zinc Oxide 25%

    Lanolin 15.5%

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  • PURPOSE

    Purpose

    Skin protectant

    Skin protectant

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  • INDICATIONS & USAGE

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

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  • WARNINGS

    Warnings For external use only

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  • WHEN USING

    When using this product ● Do not get into eyes

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  • 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

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  • 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

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  • 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

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  • 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

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  • INACTIVE INGREDIENT

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

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  • INGREDIENTS AND APPEARANCE
    CAPENT  DIAPER RASH
    zinc oxide lanolin ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59567-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 g  in 100 g
    LANOLIN (LANOLIN) LANOLIN 15.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALLANTOIN  
    BENZALKONIUM CHLORIDE  
    BUTYLATED HYDROXYANISOLE  
    COD LIVER OIL  
    GLYCERYL MONOSTEARATE  
    MINERAL OIL  
    PARAFFIN  
    PETROLATUM  
    PROPYL GALLATE  
    TALC  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59567-001-42 42.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 03/01/2013
    Labeler - Laboratorios Columbia S.A. de C.V. (812685253)
    Establishment
    Name Address ID/FEI Business Operations
    Laboratorios Columbia S.A. de C.V. 812685253 manufacture(59567-001)
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