Capent
FDA Label NDC 59567-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Columbia S.a. De C.v. for the product Capent (NDC 59567-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients

Zinc Oxide 25%

Lanolin 15.5%

Otc - 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

Otc - When Using

When using this product ● Do not get into eyes

Otc - 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

Otc - 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

Other

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

Package Label.Principal Display Panel

Image Description (Capentlbl)

Image Description (Capentlbl)

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