Baza Protect Cream
FDA Label NDC 11701-046

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 Protect (NDC 11701-046). 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

  • Protects
  • Easy to apply and remove
  • Seals out wetness

    • Drug Facts

    For external use only.

Otc - Active Ingredient

Active ingredients

Zinc Oxide, 12%

Dimethicone, 1 %

Otc - Purpose

Purpose

Diaper Rash

Skin Protectant

Indications & Usage

Uses Helps treat and prevent minor skin irritation due to

diaper rash. 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 the reach of children. If swallowed, get medical help or contact a Poison Control

Center right away.

Dosage & Administration

Directions

  • change wet and soiled diapers promptly
  • apply to affected area and gently wipe with clean, soft cloth
  • apply 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

BHT, cetyl alcohol, cod liver oil, EDTA, fragrance, glyceryl stearate, lanolin oil, PEG-8 stearate, PEG-40 stearate, petrolatum, propylene glycol, quaternium-15, tocopheryl acetate, tricontanyl PVP, water

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.cobplast.com
Product #1880 ©2008-7, Coloplast Corp.
Made in the U.S.A.

G8-773

Package Label.Principal Display Panel

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

NDC 11701-046-14

Baza®Protect

Skin Protectant

Moisture Barrier Cream

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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