Label: CAPENT DIAPER RASH- zinc oxide lanolin ointment
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Contains inactivated NDC Code(s)
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
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
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAPENT DIAPER RASH
zinc oxide lanolin ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59567-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 g in 100 g LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN 15.5 g in 100 g Inactive Ingredients Ingredient Name Strength 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 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)