Baza Protect Cream
FDA Label NDC 11701-082

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 11701-082). 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, active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark

Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A.

Active Ingredients

Zinc Oxide, 12%
Dimethicone, 1%

Purpose

Skin Protectant

Uses

  • Helps prevent and temporarily protects chafed, chapped or cracked skin.
  • Helps seal out wetness.

Warnings

For external use only.

When Using This Product

  • Do not get into eyes.
  • Do not use on:
    • deep or puncture wounds
    • animal bites
    • serious burns.

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few 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.

Directions

  • Apply to affected area and gently wipe with clean, soft cloth.
  • Apply as needed, especially at bedtime or any time when exposure to moisture may be prolonged.

Inactive Ingredients

Water, petrolatum, lanolin oil, propylene glycol, PEG- 40 stearate, cetyl alcohol, PEG-8 stearate, glyceryl stearate, triacontanyl PVP, fragrance, caprylyl glycol, caprylhydroxamic acid, ethylhexylglycerin, propanediol, tocopheryl acetate, EDTA

Principal Display Panel - 142 G Tube Label

NDC 11701-082-24

Baza® Protect

Skin Protectant

Moisture
Barrier Cream

For Skin Irritation
Due to Incontinence

Coloplast

NET WT. 5 OZ. (142 g)

Principal Display Panel (142 g Tube Label)

Principal Display Panel (142 g Tube Label)

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