Baza Cleanse And Protect Lotion
FDA Label NDC 11701-047

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 Cleanse And Protect (NDC 11701-047). 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 At-Risk Skin Irritation Due to Incontinence

Drug Facts

For external use only.

Otc - Active Ingredient

Active ingredient

Dimethicone, 2%

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
  • spray 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 allantoin, cetearyl alcohol, citric acid, diazolidinyl urea, glycerin, glyceryl stearate, isopropyl palmitate, methylparaben, panthenol, propylene glycol, propylparaben, sodium lauroyl lactylate, soybean oil, tocopheryl acetate (vitamin E), water

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 #7712
©2008-9, Coloplast Corp. Made in the U.S.A.

J8-1115

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL - 8 FL. OZ. (237 mL)

NDC 11701-047-05

Baza Cleanse & Protect®

Skin Protectant

All-In-One Perineal Lotion

For At-Risk Skin Irritation Due to Incontinence

Coloplast

8 FL. OZ. (237 mL)

Principal Display Panel (8 FL. OZ. (237 mL))

Principal Display Panel (8 FL. OZ. (237 mL))

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