Baza Clear Ointment
FDA Label NDC 11701-048

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coloplast Corp for the product Baza Clear (NDC 11701-048). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

For Skin Irritation Due to Incontinence

Drug Facts

For external use only.

Otc - Active Ingredient

Active ingredient

Petrolatum, 96%

Otc - Purpose

Purpose

Skin Protectant

Indications & Usage

Uses Helps treat and prevent minor skin irritation due to diaper rash. Helps prevent and temporarily protects chafed, chapped or cracked skin. Helps seal out wetness.

Warnings

Warnings

Otc - When Using

When using this product

  • avoid contact with eyes
  • not to be applied over deep or puncture wounds or lacerations.

Otc - Ask Doctor

Consult a doctor

  • if condition worsens or does not improve within 7 days.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • apply liberally as often as necessary.

    • For Diaper Rash: cleanse the diaper area and allow to dry

    • apply liberally as often as necessary, with each diaper change especially at bedtime or any time when exposure to wet diapers may be prolonged.

Inactive Ingredient

Inactive ingredients benzethonium chloride, BHT, cod liver oil, fragrance, green 6, sodium caseinate (CONTAINS MILK)

See crimp for lot no. and expiration date

Manufactured by: Coloplast A/S
DK-3050 Humlebaek, Denmark
Distributed by: Coloplast Corp.
Minneapolis, MN 55411 U.S.A.
1-800-533-0464 www.us.coloplast.com
Product #1006 ©2008-7, Coloplast Corp.
Made in the U.S.A.

G8-303

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g)

NDC 11701-048-014

Baza®Clear

Skin Protectant

Moisture Barrier Ointment

For Skin Irritation Due to Incontinence

Coloplast

NET WT. 5 OZ. (142 g)

Principal Display Panel (NET WT. 5 OZ. (142g))

Principal Display Panel (NET WT. 5 OZ. (142g))

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