Zinc Oxide
FDA Label NDC 58029-223

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gerimedix Incorporated for the product Zinc Oxide (NDC 58029-223). 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 otc - active ingredient, purpose:, warnings:, when using this product:, stop use and ask a doctor if:, dosage & administration, keep out of reach of children., other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient               Purpose

Zinc Oxide (1.8% w/w)      Skin Protectant

Purpose:

  • Helps treat and prevent diaper rash
  • Temporarily protects
  • minor cuts
  • scrapes and
  • burns
  • dries the oozing and weeping of
  • poison ivy
  • poison oak
  • poison sumac

Warnings:

For External Use Only.

When Using This Product:

Do not get in eyes.

Stop Use And Ask A Doctor If:

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Dosage & Administration

For skin protectant:
Apply liberally as needed
For diaper Rash:
change wet and soiled diapers promptly
allow to dry
apply ointment liberally with each diaper change

Keep Out Of Reach Of Children.

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

Other Information:

  • Store at room temperature
  • avoid excessive heat
  • contains color additives including FDC yellow # 5

Indications & Usage

Indications: For use as a general skin protectant and diaper rash.

Inactive Ingredients

Inactive ingredients:

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-10, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Polyethylene Glycol 6000, Polysorbate 60, Propylparaben Sodium, Steareth-20, Trolamine, Vitamin A, Water


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Geriguard Skin Protectant

Zinc Oxide Ointment

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Zinc_oxide (Zinc Oxide)

Zinc_oxide (Zinc Oxide)

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