Z-bum Cream
FDA Label NDC 58809-375

12 label sections · Submitted to the FDA by Gm Pharmaceuticals, Inc · 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

→ Purpose

→ Uses

→ Warnings

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

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 20-30°C (68-86°F)

Inactive Ingredients

aloe barbadensis leaf juice, caprylyl glycol, ceteareth- 20, cetyl alcohol, chlorphenesin, glycerine, mineral oil, petrolatum, phenoxyethanol, purified water, stearyl alcohol, tocopheryl acetate (vitamin E)