CAPENT DIAPER RASH- zinc oxide and lanolin ointment 
Laboratorios Columbia S.A. de C.V.

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.

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Active Ingredients

Zinc Oxide 25%

Lanolin 15.5%

Purpose

Skin protectant

Skin protectant

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

Warnings For external use only

When using this product ● Do not get into eyes

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. If swallowed get medical help or contact a Poison Control Center right away

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

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

image description

CAPENT  DIAPER RASH
zinc oxide lanolin ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59567-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE25 g  in 100 g
LANOLIN (LANOLIN) LANOLIN15.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
BENZALKONIUM CHLORIDE 
BUTYLATED HYDROXYANISOLE 
COD LIVER OIL 
GLYCERYL MONOSTEARATE 
MINERAL OIL 
PARAFFIN 
PETROLATUM 
PROPYL GALLATE 
TALC 
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)

Revised: 2/2013
Document Id: 8679eaaa-9637-4fb5-af98-5af021179636
Set id: fe994e8c-147d-44ae-b437-930db3f42bd3
Version: 1
Effective Time: 20130218
 
Laboratorios Columbia S.A. de C.V.