Z-bum Cream
FDA Label NDC 58809-375

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gm Pharmaceuticals, Inc for the product Z-bum (NDC 58809-375). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide 22%

Purpose

Skin Protectant

Uses

  • helps treat and prevent diaper rash.
  • protects chafed skin due to diaper rash and helps protect skin from wetness.

Warnings

For external use only.

When Using This Product

  • do not get into eyes.

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.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
  • Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other Information

  • Store at 68-77° F (20-25° C) [see USP Controlled Room Temperature]
  • Lot No and Exp Date: see box or see crimp of tube.

Inactive Ingredients

Purified Water, White Petrolatum, Glycerine, Light Mineral Oil, Cetyl Alcohol, Stearyl Alcohol, Ceteareth- 20, Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Chlorphenesin, Phenoxyethanol, and Tocopheryl Acetate (Vitamin E).\

Questions Or Comments?

1-888-535-0305

Manufactured for:
GM Pharmaceuticals, Inc.

Arlington, TX 76015

P1117.00

R071216

Principal Display Panel

NDC58809-375-04
Z-BUM
Daily Moisturizing Diaper Rash Cream
NET WT 4 oz (113 grams)

* Please review the disclaimer below.