CAPENT DIAPER RASH- zinc oxide lanolin ointment

Capent by

Drug Labeling and Warnings

Capent by is a Otc medication manufactured, distributed, or labeled by Laboratorios Columbia S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CAPENT  DIAPER RASH
zinc oxide lanolin ointment

Product 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)